Amended in Senate June 24, 2014

Amended in Senate June 4, 2014

Amended in Senate May 21, 2014

Amended in Senate July 11, 2013

Amended in Assembly May 8, 2013

Amended in Assembly March 12, 2013

California Legislature—2013–14 Regular Session

Assembly BillNo. 333


Introduced by Assembly Member Wieckowski

February 13, 2013


An act to amend Sections 117605, 117665, 117695, 117700, 117710, 117725, 117747, 117765, 117775,begin insert 117780,end insert 117805, 117820, 117835, 117885, 117890, 117900, 117903, 117904, 117918, 117920,begin delete 117924,117935,end deletebegin insert 117924, 117935,end insert117938, 117940, 117943, 117945, 117950, 117960, 117970,begin insert 117985,end insert 117990, 118000, 118025, 118027, 118029, 118032, 118045, 118135, 118150, 118155, 118160, 118205, 118215, 118220, 118222, 118240, 118245, 118275, 118280, 118286, 118307, 118321.1, 118321.5, 118335, and 118345 of, to add Sections 117636, 117647,begin delete 117663, 117664,end delete 117946, 117967, and 117976 to, to repeal Sections 117620, 117635, 117748, 117755, 117777,begin delete 117895, 117915,end delete 117933, 117955,begin delete 117980, 117985,end delete118005, 118030, and 118040 of, and to repeal and add Sections 117630,begin delete 117662,end delete 117690, 117750, 117770,begin delete 117780,end deletebegin insert 117895,end insert and 117975 of, the Health and Safety Code, relating to medical waste.

LEGISLATIVE COUNSEL’S DIGEST

AB 333, as amended, Wieckowski. Medical waste.

(1) Existing law, the Medical Waste Management Act, regulates the disposal of medical waste, including requiring specified biohazard materials to be disposed of in biohazard bags and requiring specified treatment for medical waste. Transportation, storage, treatment, or disposal of medical waste in a manner not authorized by the act is a crime. Existing law defines specified terms for purposes of the Medical Waste Management Act, including “biohazard bag,” “medical waste management plan,”begin delete “health care professional,”end delete “sharps container,” “shipping document,” and “treatment.” Under existing law, health care professionals who generate medical waste are generally required to have medical waste transported by a registered hazardous waste transporter.begin delete Under existing law, a health care professional is a person licensed under specified provisions, including dentists and physicians and surgeons.end delete

This bill would specify that the United States Department of Transportation has responsibility for the transportation of medical waste on public roads and highways and that the United States Postal Service has responsibility for the transportation of medical waste through the mail. The bill wouldbegin delete remove andend deletebegin insert delete orend insert recast provisions of the act that are inconsistent with that authority. The bill would also redefine the specified terms for purposes of the Medical Waste Management Act, including those above,begin insert andend insert add definitions of terms, including a chemotherapeuticbegin delete agent, and expand the scope of a health care professional to include any person who generates medical waste in a health care setting or in the course of providing health care servicesend deletebegin insert agentend insert. The bill would include all subsets of waste in the definition of treatment. The bill would also authorize the color coding of sharps containers to segregate the waste stream if designated in the medical waste management plan.

(2) Existing law authorizes a local agency to adopt a medical waste management program to, among other things, issue medical waste registrations and permits and inspect medical waste generators and treatment facilities, and requires the local agency, if it elects to do so, to notify the department. Under existing law, if the local agency chooses not to adopt a medical waste management program or if the department withdraws its designation, then the department is the enforcement agency.

Existing law requires the department to impose and cause to be collected an annual medical waste generator fee, as specified. Existing law authorizes the department to contract with a medical waste transporter or provider of medical waste mail-back systems for the collection of these fees and authorizes the collecting body to recover not more than 5% of the fees as administrative costs.

This bill would remove the ability of the department to use medical waste mail-back systems for the collection of these fees and would authorize medical waste transporters that collect these fees to recover up to 7.5% as administrative costs.

(3) Under the Medical Waste Management Act, medical waste generators, including large quantity generators and small quantity generators, are subject to various requirements relating to registration, record retention, and transportation of medical waste.

This bill would revise the registration procedures and the record requirements for large quantity and small quantity generators. The bill would require large and small quantity generators that operate treatment equipment to receive annual training to operate the equipment. The bill would exempt from regulation as a hazardous waste hauler a small quantity generator or large quantity generator that meets specified requirements, including retaining specified documentation and complying with certain federal requirements relating to a materials of trade exception.

The bill would make technical, conforming, and clarifying changes relating to these provisions.

Existing law prohibits a large quantity generator from generating medical waste unless the large quantity generator is registered with the enforcement agencybegin insert and requires small quantity generators to register with the local enforcement agencyend insert.

This bill would authorize abegin insert registeredend insert large quantitybegin insert or small quantityend insert medical waste generatorbegin delete who is registered with the enforcement agencyend delete to generate medical waste at a temporary event, including vaccination clinics, and would require the large quantitybegin insert or small quantityend insert generator to notify the enforcement agency of its participation at such an eventbegin insert at least 72 hours before the eventend insert.

(4) Existing law requires that all medical waste be hauled by either a registered hazardous waste hauler or by a person with an approved limited-quantity exemption granted pursuant to specified provisions of law. Existing law also specifies treatment methods and processes that medical waste treatment facilities are required to use, including requiring heat sensitive tape to show that materials went through a heat process, and requires a medical waste treatment facility to be permitted by the department.

This bill would makebegin delete specifiedend deletebegin insert variousend insert changes to the provisions relating to medical waste haulers, including removing provisions that conflict with the United States Department of Transportation regulation of those entitiesbegin insert, authorizing a registered trauma scene waste practitioner, as specified, to haul medical waste,end insert and making changes to the information medical waste haulers are required to provide to the department annually. This bill would also make various changes to the provisions relating to medical waste treatment facilities, including specifying the decontamination methods for a closure plan, lowering the time period for which records are maintained from 3 to 2 years, and authorizing the use of electronic information for operating records and shipping documents.

(5) Existing law exempts from specified provisions of the Medical Waste Management Act a person who is authorized to collect solid waste and who unknowingly transports medical waste to a solid waste facility, incidental to the collection of solid waste.

This bill would exempt those persons from the entire act, with regard to that waste, and would require the solid waste transporter to contact the originating generator of the medical waste to respond to the facility to provide ultimate proper disposal of the medical waste.

(6) Existing law requires that animals that die of infectious diseases be treated as medical waste, as specified, if, in the opinion of the attending veterinarian or local health officer, the carcass presents a danger of infection to humans.

This bill would require the carcasses of animals that have died of infectious diseases or that have been euthanized because of suspected exposure to infectious disease to be treated with a treatment technology approved by the department if, in the opinion of the attending veterinarian or local health officer, the carcass presents a danger of infection to humans. By expanding the definition of a crime, this bill would create a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: yes.

The people of the State of California do enact as follows:

P5    1

SECTION 1.  

Section 117605 of the Health and Safety Code
2 is amended to read:

3

117605.  

begin delete(a)end deletebegin deleteend deleteThe United States Department of Transportation
4(USDOT) is responsible for the transportation of medical waste
5on public roads and highways. The United States Postal Service
6(USPS) is responsible for the transportation of medical waste
7through the mail and approves medical waste mail-back systems.
8The standards USDOT enforces are found in Title 49 of the Code
9of Federal Regulations. The standards USPS enforces are found
10in Domestic Mail Manual 601.10.17.5 (Mailability: Hazardous
11Materials: Sharps and Other Mailable Regulated Medical Waste).
12The USDOT and USPS regulations preempt state laws.

begin delete

13(b) The Medical Waste Management Act does not preempt any
14local ordinance regulating infectious waste, as that term was
15defined by Section 25117.5 as it read on December 31, 1990, if
16the ordinance was in effect on January 1, 1990, and regulated both
17large and small quantity generators. Any ordinance may be
18amended in a manner that is consistent with this part.

end delete
19

SEC. 2.  

Section 117620 of the Health and Safety Code is
20repealed.

21

SEC. 3.  

Section 117630 of the Health and Safety Code is
22repealed.

23

SEC. 4.  

Section 117630 is added to the Health and Safety Code,
24to read:

25

117630.  

“Biohazard bag” means a disposable film bag that is
26impervious to moisture. The film bags that are used for transport
27shall be marked and certified by the manufacturer as having passed
28the tests prescribed for tear resistance in the American Society for
29Testing Materials (ASTM) D1922, “Standard Test Method for
30Propagation Tear Resistance of Plastic Film and Thin Sheeting by
31Pendulum Method” and for impact resistance in ASTM D 1709,
32“Standard Test Methods for Impact Resistance of Plastic Film by
33the Free-Falling Dart Method,” as those documentsbegin delete areend deletebegin insert wereend insert
34 published on January 1, 2014. The film bag shall meet an impact
35resistance of 165 grams and a tearing resistance of 480 grams in
P6    1both parallel and perpendicular planes with respect to the length
2of the bag. The color of the bag shall be red, except when other
3colors are used to further segregate the waste stream, including
4for trace chemotherapy wastes, laboratory wastes, and other subsets
5of the waste stream. If additional colors are used other than the
6standard red bag, the color assignments shall be designated in the
7facility’s medical waste management plan.

8

SEC. 5.  

Section 117635 of the Health and Safety Code is
9repealed.

10

SEC. 6.  

Section 117636 is added to the Health and Safety Code,
11to read:

12

117636.  

“Chemotherapeutic agent” means an agent that kills
13or prevents the reproduction of malignant cells. Chemotherapeutic
14agent excludes anti-inflammatory and antibiotic medications used
15to treat malignant cells in the practice of veterinary medicine.

16

SEC. 7.  

Section 117647 is added to the Health and Safety Code,
17to read:

18

117647.  

“Empty tubing or container” means a condition
19achieved when tubing, a container, or inner liner removed from a
20container that previously contained liquid or solid material,
21including, but not limited to, a chemotherapeutic agent, is
22considered empty. The tubing, container, or inner liner removed
23from the container shall be considered empty if it has been emptied
24so that the following conditions are met:

25(a) If the material that the tubing, container, or inner liner held
26is pourable, no material can be poured or drained from the tubing,
27container, or inner liner when held in any orientation, including,
28but not limited to, when tilted or inverted.

29(b) If the material that the tubing, container, or inner liner held
30is not pourable, no material or waste remains in the container or
31inner liner that can feasibly be removed by scraping.

begin delete32

SEC. 8.  

Section 117662 of the Health and Safety Code is
33repealed.

end delete
begin delete34

SEC. 9.  

Section 117662 is added to the Health and Safety Code,
35to read:

36

117662.  

“Health care professional” means any person who
37generates medical waste in a health care setting or in the course
38of providing a health care service.

end delete
begin delete39

SEC. 10.  

Section 117663 is added to the Health and Safety
40Code
, to read:

P7    1

117663.  

“Health care and veterinary services” means services
2organized, delivered, and maintained for the diagnosis, care,
3immunization, prevention, and treatment of human and animal
4illness.

end delete
begin delete5

SEC. 11.  

Section 117664 is added to the Health and Safety
6Code
, to read:

7

117664.  

“Health care and veterinary settings” means a facility,
8location, place, or building that is organized, maintained, and
9operated, in whole or in part, fixed or mobile, for the diagnosis,
10care, prevention, and treatment of human and animal illness.

end delete
11

begin deleteSEC. 12.end delete
12begin insertSEC. 8.end insert  

Section 117665 of the Health and Safety Code is
13amended to read:

14

117665.  

“Highly communicable diseases” means diseases,
15such as those caused by organisms classified by the federal Centers
16for Disease Control and Prevention as risk group 3 organisms or
17higher.

18

begin deleteSEC. 13.end delete
19begin insertSEC. 9.end insert  

Section 117690 of the Health and Safety Code is
20repealed.

21

begin deleteSEC. 14.end delete
22begin insertSEC. 10.end insert  

Section 117690 is added to the Health and Safety
23Code
, to read:

24

117690.  

(a) “Medical waste” means any biohazardous,
25pathology, pharmaceutical, trace or bulk chemotherapy waste not
26regulated by the federal Resource Conservation and Recovery Act
27of 1976 (Public Law 94-580), as amended; sharps and trace
28chemotherapy wastes generated in a health care setting in the
29diagnosis, treatment, immunization, or care of humans or animals;
30waste generated in autopsy or necropsy; waste generated during
31preparation of a body for final disposition such as cremation or
32interment; waste generated in research pertaining to the production
33or testing of microbiologicals; waste generated in research using
34human or animal pathogens; sharps and laboratory waste that poses
35a potential risk of infection to humans generated in the inoculation
36of animals in commercial farming operations; waste generated
37from the consolidation of home-generated sharps; and waste
38generated in the cleanup of trauma scenes. Biohazardous,
39pathology, pharmaceutical, sharps, and trace chemotherapy wastes
40begin delete that are classified as medical wastes shall not be subjectend deletebegin insert that meet
P8    1the conditions of this section are not subjectend insert
to any of the hazardous
2waste requirements found in Chapter 6.5 (commencing with
3Section 25100) of Division 20.

4(b) For purposes of this part the following definitions apply:

5(1) “Biohazardous waste” includes all of the following:

6(A) (i) Regulated medical waste, clinical waste, or biomedical
7waste that is a waste or reusable material derived from the medical
8treatment of a human or from an animal that is suspected by the
9attending veterinarian of being infected with a pathogen that is
10also infectious to humans, which includes diagnosis and
11immunization; or from biomedical research, which includes the
12production and testing of biological products.

13 (ii) Regulated medical waste or clinical waste or biomedical
14waste suspected of containing a highly communicable disease.

15(B) Laboratory waste such as human specimen cultures or
16animal specimen cultures that are infected with pathogens that are
17also infectious to humans; cultures and stocks of infectious agents
18from research; wastes from the production of bacteria, viruses,
19spores, discarded live and attenuated vaccines used in human health
20care or research, discarded animal vaccines, including Brucellosis
21and Contagious Ecthyma, as defined by the department; culture
22dishes, devices used to transfer, inoculate, and mix cultures; and
23wastes identified by Section 173.134 of Title 49 of the Code of
24Federal Regulations as Category B “once wasted” for laboratory
25wastes.

26(C) Waste that, at the point of transport from the generator’s
27site or at the point of disposal contains recognizable fluid human
28blood, fluid human blood products, containers, or equipment
29containing human blood that is fluid, or blood from animals
30suspected by the attending veterinarian of being contaminated with
31infectious agents known to be contagious to humans.

32(D) Waste containing discarded materials contaminated with
33excretion, exudate, or secretions from humans or animals that are
34required to be isolated by the infection control staff, the attending
35physician and surgeon, the attending veterinarian, or the local
36health officer, to protect others from highly communicable diseases
37or diseases of animals that are communicable to humans.

38(2) Pathology waste includes both of the following:

39(A) Human body parts, with the exception of teeth, removed at
40surgery and surgery specimens or tissues removed at surgery or
P9    1autopsy that are suspected by the health care professional of being
2contaminated with infectious agents known to be contagious to
3humans or having been fixed in formaldehyde or another fixative.

4(B) Animal parts, tissues, fluids, or carcasses suspected by the
5attending veterinarian of being contaminated with infectious agents
6known to be contagious to humans.

7(3) “Pharmaceutical waste” means a pharmaceutical, as defined
8in Section 117747, including fluid bulk chemotherapy waste, that
9is a waste, as defined in Section 25124. For purposes of this part,
10“pharmaceutical waste” does not include a pharmaceutical that
11meets either of the following criteria:

12(A) The pharmaceutical is being sent out of the state to a reverse
13distributor, as defined in Section 4040.5 of the Business and
14Professions Code, that is licensed as a wholesaler of dangerous
15drugs by the California State Board of Pharmacy pursuant to
16Section 4161 of the Business and Professions Code.

17(B) The pharmaceutical is being sent by a reverse distributor,
18as defined in Section 4040.5 of the Business and Professions Code,
19offsite for treatment and disposal in accordance with applicable
20laws, or to a reverse distributor that is licensed as a wholesaler of
21dangerous drugs by the California State Board of Pharmacy
22pursuant to Section 4160 of the Business and Professions Code
23and as a permitted transfer station if the reverse distributor is
24located within the state.

25(4) “Sharps waste” means a devicebegin delete contaminated with
26biohazardous wasteend delete
that has acute rigid corners, edges, or
27protuberances capable of cutting or piercing, including, but not
28limited to, hypodermic needles, hypodermic needles with syringes,
29blades, needles with attached tubing, acupuncture needles, root
30canal files, broken glass items used in health care such as Pasteur
31pipettes and blood vials contaminated with biohazardous waste,
32and any item capable of cutting or piercing from trauma scene
33waste.

34(5) “Trace chemotherapeutic waste” means waste that is
35contaminated through contact with, or having previously contained,
36chemotherapeutic agents, including, but not limited to, gloves,
37disposable gowns, towels, and intravenous solution bags and
38attached tubing that are empty. A biohazardous waste that meets
39the conditions of this paragraph is not subject to the hazardous
P10   1waste requirements ofbegin delete the Department of Toxic Substances Controlend delete
2begin insert Chapter 6.5 (commencing with Section 25100) of Division 20end insert.

3(6) “Trauma scene waste” means waste that is a regulated waste,
4as defined in Section 5193 of Title 8 of the California Code of
5Regulations, and that has been removed, is to be removed, or is in
6the process of being removed, from a trauma scene by a trauma
7scene waste management practitioner.

8

begin deleteSEC. 15.end delete
9begin insertSEC. 11.end insert  

Section 117695 of the Health and Safety Code is
10amended to read:

11

117695.  

Medical waste that has been treated in accordance
12with the provisions of the Medical Waste Management Act,
13Chapter 8 (commencing with Section 118215), and that is not
14otherwise hazardous, shall thereafter be considered solid waste as
15defined in Section 40191 of the Public Resources Code and not
16medical waste.

17

begin deleteSEC. 16.end delete
18begin insertSEC. 12.end insert  

Section 117700 of the Health and Safety Code is
19amended to read:

20

117700.  

Medical waste does not include any of the following:

21(a) Waste generated in food processing or biotechnology that
22does not contain an infectious agentbegin insert, as defined in Section 117675,end insert
23 or an agent capable of causing an infection that is highly
24communicable, as defined in Section 117665.

25(b) Waste generated in biotechnology that does not contain
26human blood or blood products or animal blood or blood products
27suspected of being contaminated with infectious agents known to
28be communicable to humans or a highly communicable disease.

29(c) Urine, feces, saliva, sputum, nasal secretions, sweat, tears,
30or vomitus, unless it contains visiblebegin delete fluid bloodend deletebegin insert or recognizable
31fluid blood, as provided in subparagraph (C) of paragraph (1) of
32subdivision (b) of Section 117690end insert
.

33(d) Waste which is not biohazardous, such as paper towels,
34paper products, articles containing nonfluid blood, and other
35medical solid waste products commonly found in the facilities of
36medical waste generators.

37(e) Hazardous waste, radioactive waste, or household waste,
38including, but not limited to, home-generated sharps waste, as
39defined in Section 117671.

P11   1(f) Waste generated from normal and legal veterinarian,
2agricultural, and animal livestock management practices on a farm
3or ranch unless otherwise specified in law.

4

begin deleteSEC. 17.end delete
5begin insertSEC. 13.end insert  

Section 117710 of the Health and Safety Code is
6amended to read:

7

117710.  

“Medical waste management plan” means a document
8that is completed by generators of medical waste that describes
9how the medical waste generated at their facility shall be
10segregated, handled, stored, packaged, treated, or shipped for
11treatment, as applicable, pursuant to Section 117935 for small
12quantity generators and Section 117960 for large quantity
13generators, on forms prepared by the enforcement agency, if those
14forms are provided by the enforcement agency.

15

begin deleteSEC. 18.end delete
16begin insertSEC. 14.end insert  

Section 117725 of the Health and Safety Code is
17amended to read:

18

117725.  

begin insert(a)end insertbegin insertend insert“Medical waste treatment facility” means all land
19and structures, and other appurtenances or improvements on the
20land under the control of the treatment facility, used for treating
21medical waste offsite from a medical waste generator, including
22all associated handling and storage of medical waste as permitted
23by the department.

begin insert

24(b) For purposes of this section, land is under the control of the
25treatment facility if it is owned, rented, or controlled by contractual
26agreement.

end insert
27

begin deleteSEC. 19.end delete
28begin insertSEC. 15.end insert  

Section 117747 of the Health and Safety Code is
29amended to read:

30

117747.  

(a) “Pharmaceutical” means a prescription or
31over-the-counter human or veterinary drug, including, but not
32limited to, a drug as defined in Section 109925 of the Federal Food,
33Drug, and Cosmetic Act, as amended, (21 U.S.C.A. Sec. 321(g)(1)).

34(b) For purposes of this part, “pharmaceutical” does not include
35any pharmaceutical that is regulated pursuant to either of the
36following:

37(1) The federal Resource Conservation and Recovery Act of
381976, as amended (42 U.S.C.A. Sec. 6901 et seq.). This waste
39stream shall be handled as a hazardous waste under the authority
P12   1ofbegin delete the Department of Toxic Substances Controlend deletebegin insert Chapter 6.5
2(commencing with Section 25100) of Division 20end insert
.

3(2) The Radiation Control Law (Chapter 8 (commencing with
4Section 114960) of Part 9).

5

begin deleteSEC. 20.end delete
6begin insertSEC. 16.end insert  

Section 117748 of the Health and Safety Code is
7repealed.

8

begin deleteSEC. 21.end delete
9begin insertSEC. 17.end insert  

Section 117750 of the Health and Safety Code is
10repealed.

11

begin deleteSEC. 22.end delete
12begin insertSEC. 18.end insert  

Section 117750 is added to the Health and Safety
13Code
, to read:

14

117750.  

(a) “Sharps container” means a rigid puncture-resistant
15container used in patient care or research activities meeting the
16standards of, and receiving approval from, the United States Food
17and Drug Administration as a medical device used for the collection
18of discarded medical needles, other sharps, or, except as specified
19in subdivision (b), other waste.

20(b) For purposes of subdivision (a), “other waste” does not
21include any waste that is regulated pursuant to either of the
22following:

23(1) The federal Resource Conservation and Recovery Act of
241976, as amended (42 U.S.C. Sec. 6901 et seq.).

25(2) The Radiation Control Law (Chapter 8 (commencing with
26Section 114960) of Part 9).

27(c) No specific color of the sharps container is required. If
28multiple colored containers are used to segregate the waste stream,
29including for trace chemotherapy waste, laboratory waste, and
30other subsets of the waste stream, the color assignments for the
31sharps containers shall be designated in the generator’s medical
32waste management plan.

33(d) Sharps containers, including those used to containerize trace
34chemotherapeutic wastes, shall not be lined with a plastic bag or
35inner liner.

36

begin deleteSEC. 23.end delete
37begin insertSEC. 19.end insert  

Section 117755 of the Health and Safety Code is
38repealed.

P13   1

begin deleteSEC. 24.end delete
2begin insertSEC. 20.end insert  

Section 117765 of the Health and Safety Code is
3amended to read:

4

117765.  

“Storage” means the holding of medical wastes, in
5compliance with the Medical Waste Management Act, including
6Chapter 9 (commencing with Section 118275), at a designated
7accumulation area, offsite point of consolidation, transfer station,
8other registered facility, or in a vehicle detached from its means
9of locomotion.

10

begin deleteSEC. 25.end delete
11begin insertSEC. 21.end insert  

Section 117770 of the Health and Safety Code is
12repealed.

13

begin deleteSEC. 26.end delete
14begin insertSEC. 22.end insert  

Section 117770 is added to the Health and Safety
15Code
, to read:

16

117770.  

“Shipping document” means the medical waste
17shipping document required by the United States Department of
18Transportation pursuant to Section 172.200 et seq. of Title 49 of
19the Code of Federal Regulations or the document required by the
20United States Postal Service pursuant to Domestic Mail Manual
21601.10.17.5 (Mailability: Hazardous Materials: Sharps and Other
22Mailable Regulated Medical Waste).

23

begin deleteSEC. 27.end delete
24begin insertSEC. 23.end insert  

Section 117775 of the Health and Safety Code is
25amended to read:

26

117775.  

(a) “Transfer station” means an offsite location
27permitted by the department where medical waste is loaded,
28unloaded, stored, or consolidated by a registered hazardous waste
29hauler during the normal course of transportation of the medical
30waste.

31(b) “Transfer station” does not include any onsite facility,
32including, but not limited to, common storage facilities, facilities
33of medical waste generators employed for the purpose of
34consolidation, or onsite treatment facilities.

35

begin deleteSEC. 28.end delete
36begin insertSEC. 24.end insert  

Section 117777 of the Health and Safety Code is
37repealed.

begin delete
38

SEC. 29.  

Section 117780 of the Health and Safety Code is
39repealed.

P14   1

SEC. 30.  

Section 117780 is added to the Health and Safety Code,
2to read:

3

117780.  

“Treatment” includes any of the following:

4(a) Treatment for biohazardous waste is any method, technique,
5or process designed to change the biological character or
6composition of any biohazardous medical waste so as to eliminate
7its potential for causing disease.

8(b) Treatment of pathology waste is any method, technique, or
9process to destroy the biological character or composition of any
10pathology medical waste so as to eliminate its potential for creating
11public or environmental health harm.

12(c) Treatment for pharmaceutical waste is any method,
13technique, or process designed to destroy the character or
14composition of any pharmaceutical medical waste so as to eliminate
15its potential for creating public or environmental health harm.

16(d) Treatment for sharps waste is any method, technique, or
17process designed to change the biological character or composition
18of any biohazardous material found on the sharp so as to eliminate
19its potential for causing disease.

20(e) Treatment for trace chemotherapeutic waste is any method,
21technique, or process designed to destroy the character or
22composition of any trace chemotherapeutic medical waste so as
23to eliminate its potential for creating public or environmental health
24harm.

25(f) Treatment for trauma scene waste is any method, technique,
26or process designed to change the biological character or
27composition of trauma scene medical waste so as to eliminate its
28potential for causing disease.

end delete
29begin insert

begin insertSEC. 25.end insert  

end insert

begin insertSection 117780 of the end insertbegin insertHealth and Safety Codeend insertbegin insert is
30amended to read:end insert

31

117780.  

“Treatment” means any method, technique, or process
32designed to changebegin insert or destroyend insert the biological character or
33composition of any medical waste so as to eliminate its potential
34for causing diseasebegin insert or creating public or environmental harmend insert, as
35specified in Chapter 8 (commencing with Section 118215).

36

begin deleteSEC. 31.end delete
37begin insertSEC. 26.end insert  

Section 117805 of the Health and Safety Code is
38amended to read:

P15   1

117805.  

A local agency that elects to implement a medical
2waste management program shall notify the department of its intent
3to do so.

4

begin deleteSEC. 32.end delete
5begin insertSEC. 27.end insert  

Section 117820 of the Health and Safety Code is
6amended to read:

7

117820.  

A medical waste management program shall include,
8but not be limited to, all of the following:

9(a) Issuing medical waste registrations and permits pursuant to
10the Medical Waste Management Act.

11(b) Processing and reviewing the medical waste management
12plans and inspecting onsite treatment facilities in accordance with
13Chapter 4 (commencing with Section 117925) for all small quantity
14medical waste generators required to be registered.

15(c) Conducting an evaluation, inspection, or records review for
16all facilities or persons issued a large quantity medical waste
17registration pursuant to Chapter 5 (commencing with Section
18 117950) or issued a permit for an offsite or onsite medical waste
19treatment facility pursuant to Chapter 7 (commencing with Section
20118130).

21(d) Inspecting medical waste generators in response to
22complaints or emergency incidents, or as part of an investigation
23or evaluation of the implementation of the medical waste
24management plan.

25(e) Inspecting medical waste treatment facilities in response to
26a complaint or as part of an investigation or emergency incident.

27(f) Taking enforcement action for the suspension or revocation
28of medical waste permits issued by the local agency pursuant to
29this part.

30(g) Referring or initiating proceedings for civil or criminal
31prosecution of violations specified in Chapter 10 (commencing
32with Section 118335).

33(h) Reporting in a manner determined by the department so that
34the statewide effectiveness of the program can be determined.

35

begin deleteSEC. 33.end delete
36begin insertSEC. 28.end insert  

Section 117835 of the Health and Safety Code is
37amended to read:

38

117835.  

The department shall establish and maintain a database
39of persons registered as small quantity generators and as large
40quantity generators for whom the department is the enforcement
P16   1agencybegin insert under Chapter 4 (commencing with Section 117925) and
2Chapter 5 (commencing with Section 117950)end insert
.

3

begin deleteSEC. 34.end delete
4begin insertSEC. 29.end insert  

Section 117885 of the Health and Safety Code is
5amended to read:

6

117885.  

(a) There is in the State Treasury the Medical Waste
7Management Fund, that shall be administered by the director.
8Money deposited in the fund shall be available to the department,
9upon appropriation by the Legislature, for the purposes of this part.

10(b) In addition to any other funds transferred by the Legislature
11to the Medical Waste Management Fund, the following shall be
12deposited in the fund:

13(1) Fees, penalties, interest earned, and fines collected by, or
14on behalf of, the department pursuant to this part.

15(2) Funds granted by the federal government for purposes of
16carrying out this part.

17

begin deleteSEC. 35.end delete
18begin insertSEC. 30.end insert  

Section 117890 of the Health and Safety Code is
19amended to read:

20

117890.  

(a) No large quantity generator shall generate medical
21waste unless the large quantity generator is registered with the
22enforcement agency pursuant to this part.

23(b) Registration pursuant to this part shall also allow the large
24quantity generator to generate medical waste at temporary events,
25including, but not limited to, health fairs, vaccination clinics, and
26veteran stand downs, without further registration or permitting
27required. The large quantity generator shall notify the local
28enforcement agency of their intended participation in a temporary
29eventbegin insert at least 72 hours before the eventend insert.

30

begin deleteSEC. 36.end delete
31begin insertSEC. 31.end insert  

Section 117895 of the Health and Safety Code is
32repealed.

33begin insert

begin insertSEC. 32.end insert  

end insert

begin insertSection 117895 is added to the end insertbegin insertHealth and Safety
34Code
end insert
begin insert, to read:end insert

begin insert
35

begin insert117895.end insert  

Registration pursuant to this part shall allow a small
36quantity generator to generate medical waste at temporary events,
37including, but not limited to, health fairs, vaccination clinics, and
38veteran stand downs, without further registration or permitting
39required. The small quantity generator shall notify the local
P17   1enforcement agency of their intended participation in a temporary
2event at least 72 hours before the event.

end insert
3

begin deleteSEC. 37.end delete
4begin insertSEC. 33.end insert  

Section 117900 of the Health and Safety Code is
5amended to read:

6

117900.  

No person shall haul medical waste unless the person
7is one of the following:

8(a) A registered hazardous waste hauler pursuant to the
9requirements ofbegin delete the Department of Toxic Substances Controlend delete
10begin insert Chapter 6.5 (commencing with Section 25100) of Division 20end insert.

11(b) A mail-back system approved by the United States Postal
12Service.

13(c) A common carrier allowed to haul pharmaceutical waste
14pursuant to Section 118029 or 118032.

15(d) A small quantity generator or a large quantity generatorbegin delete that
16hasend delete
begin insert transporting limited quantities of medical waste withend insert an
17exemption granted pursuant to either Section 117946 or Section
18117976, respectively.

begin insert

19(e) A registered trauma scene waste practitioner hauling trauma
20scene waste pursuant to Section 118321.5.

end insert
21

begin deleteSEC. 38.end delete
22begin insertSEC. 34.end insert  

Section 117903 of the Health and Safety Code is
23amended to read:

24

117903.  

No person shall treat medical waste unless the person
25is permitted by the enforcement agency as required by this part or
26unless the treatment is performed by a medical waste generator
27and is a treatment method approved pursuant to Chapter 8
28(commencing with Section 118215).

29

begin deleteSEC. 39.end delete
30begin insertSEC. 35.end insert  

Section 117904 of the Health and Safety Code is
31amended to read:

32

117904.  

(a) In addition to the consolidation points authorized
33pursuant to Section 118147, the enforcement agency may approve
34a location as a point of consolidation for the collection of
35home-generated sharps waste, which, after collection, shall be
36transported and treated as medical waste.

37(b) A consolidation location approved pursuant to this section
38shall be known as a “home-generated sharps consolidation point.”

39(c) A home-generated sharps consolidation point is not subject
40to the requirements of Chapter 9 (commencing with Section
P18   1118275), to the permit or registration requirements of this part, or
2to any permit or registration fees, with regard to the activity of
3 consolidating home-generated sharps waste pursuant to this section.

4(d) A home-generated sharps consolidation point shall comply
5with all of the following requirements:

6(1) All sharps waste shall be placed in sharps containers.

7(2) Sharps containers ready for disposal shall not be held for
8more than seven days without the written approval of the
9enforcement agency.

10(e) An operator of a home-generated sharps consolidation point
11approved pursuant to this section shall not be considered the
12generator of that waste, but shall be listed on the shipping document
13in compliance with United States Department of Transportation
14and United States Postal Service requirements.

15(f) The medical waste treatment facility which treats the sharps
16waste subject to this section shall maintain the shipping documents
17required by Section 118165 with regard to that sharps waste.

begin delete18

SEC. 40.  

Section 117915 of the Health and Safety Code is
19repealed.

end delete
20

begin deleteSEC. 41.end delete
21begin insertSEC. 36.end insert  

Section 117918 of the Health and Safety Code is
22amended to read:

23

117918.  

Medical waste shall be treated using treatment
24technologies approved by the department in accordance with
25Chapter 8 (commencing with Section 118215).

26

begin deleteSEC. 42.end delete
27begin insertSEC. 37.end insert  

Section 117920 of the Health and Safety Code is
28amended to read:

29

117920.  

The fee schedule specified in Section 117923 shall be
30for the issuance of medical waste registrations and for conducting
31inspections pursuant to this chapter when the department serves
32as the enforcement agency for small quantity generators. This fee
33schedule shall be adjusted annually in accordance with Section
34100425 to reflect the actual costs of implementing this chapter.
35Local enforcement agencies shall set fees that shall be sufficient
36to cover their costs in implementing this part with regard to small
37quantity generators required to be registered pursuant to Section
38117925.

P19   1

begin deleteSEC. 43.end delete
2begin insertSEC. 38.end insert  

Section 117924 of the Health and Safety Code is
3amended to read:

4

117924.  

(a) When the department is the enforcement agency,
5the department shall impose and cause the collection of an annual
6medical waste generator fee in an amount not to exceed twenty-five
7dollars ($25) on small quantity generators of medical waste, except
8for those small quantity generators that are required to register
9pursuant to Section 117925 and those generators generating only
10pharmaceutical waste as defined in paragraph (3) of subdivision
11(b) of Section 117690. Nothing in this part shall prevent the
12department from contracting with entities other than the department
13for these fee collection activities or from entering into agreements
14with medical waste transporters for the collection of these fees, if
15the department determines that such a fee collection arrangement
16would be cost effective.

17(b) If the department determines to enter into a contract with a
18medical waste transporter for the collection of the fees, the
19department shall do all of the following:

20(1) Establish that not more than 7.5 percent of the fees collected
21may be recovered by the medical waste transporter as
22administrative costs for the collection of those fees.

23(2) Establish that the administrative costs for the collection of
24the fees shall be the same for all medical waste transporters.

25(3) Prohibit any medical waste transporter from waiving the
26generator fee without the written approval of the department and
27only if the medical waste generator has made a written request for
28the waiver.

29(4) Require the medical waste transporter to report the fees
30collected pursuant to subdivision (a) to the department.

31(5) Prohibit the medical waste transporter from assuming the
32role of the department as an enforcement agent for purposes of
33collecting the medical waste generator fees.

34(6) Require medical waste transporters to include the following
35language in at least 12-point type on their invoices to medical
36waste generators:

37“Pursuant to Section 117924 of the California Health and Safety
38Code, the State Department of Public Health has contracted with
39us to collect your annual medical waste generator fee. The
40department may offset our costs of collection and administration
P20   1in an amount that may not exceed 7.5 percent of the fee collected.
2We may not waive the fee without written approval of the
3department, and only if you have made a written request for the
4waiver.”

5(7) Ensure that generators subject to this section are required
6to pay the fee only once per year.

7

begin deleteSEC. 44.end delete
8begin insertSEC. 39.end insert  

Section 117933 of the Health and Safety Code is
9repealed.

10

begin deleteSEC. 45.end delete
11begin insertSEC. 40.end insert  

Section 117935 of the Health and Safety Code is
12amended to read:

13

117935.  

begin deleteAny end deletebegin insertA end insertsmall quantity generator required to register
14with the enforcement agency pursuant to Section 117930 shall file
15with the enforcement agency a medical waste management planbegin delete,
16containing, but notend delete
begin insert on forms prescribed by the enforcement agency,
17if provided. The plans shall contain, but are notend insert
limited to, all of
18the followingbegin delete that applyend delete:

19(a) The name of the person.

20(b) The business address of the person.

21(c) The type of business.

22(d) The types, and the estimated average monthly quantity, of
23medical waste generated.

24(e) The type of treatment used onsite.

25(f) The name and business address of the registered hazardous
26waste hauler used by the generator for backup treatment and
27disposal, for waste when the onsite treatment method is not
28appropriate due to the hazardous or radioactive characteristics of
29the waste.

30(g) The name of the registered hazardous waste hauler used by
31the generator to have untreated medical waste removed for
32treatment and disposalbegin insert, if applicableend insert.

33(h) The name of the common carrier used by the generator to
34transport pharmaceutical waste offsite for treatment and disposal
35pursuant to Section 118032begin insert, if applicableend insert.

36(i) begin deleteThe end deletebegin insertIf applicable, the end insertsteps taken to categorize the
37pharmaceutical wastes generated at the facility to ensure that the
38wastes are properly disposed of as follows:

P21   1(1) Pharmaceutical wastes classified by the federal Drug
2 Enforcement Agency (DEA) as “controlled substances” are
3disposed of in compliance with DEA requirements.

4(2) The name and business address of thebegin insert registeredend insert hazardous
5waste hauler used by the generator to have wastes that are not
6regulated pursuant to the federal Resource Conservation and
7Recovery Act of 1976 and nonradioactive pharmaceutical wastes
8regulated as medical waste safely removed for treatment in
9compliance with subdivision (b) of Section 118222 as waste
10requiring specific methods.

11(j) A closure plan for the termination of treatment at the facility
12begin insert using, at a minimum, one of the methods of decontamination
13specified in subdivision (a) or (b) of Section 118295, thereby
14rendering the property to an acceptable sanitary condition
15following the completion of treatment services at the siteend insert
.

16(k) A statement certifying that the information provided is
17complete and accurate.

18

begin deleteSEC. 46.end delete
19begin insertSEC. 41.end insert  

Section 117938 of the Health and Safety Code is
20amended to read:

21

117938.  

(a) Small quantity generators using onsite steam
22sterilization, incineration, or microwave technology to treat medical
23waste are subject to biennial inspection of that onsite treatment
24facility by the enforcement agency and may be subject to the
25permitting requirements for onsite medical waste treatment
26facilities as determined by the enforcement agency.

27(b) The permitting requirements of subdivision (a) do not apply
28when onsite steam sterilization is used for the treatment or disposal
29of medical waste.

30(c) begin insert(1)end insertbegin insertend insert The operators of the treatment equipment specified in
31subdivision (a) shall be required to receive training in the operation
32of the treatment equipment, proper protective equipment to wear,
33if any, how to clean up spills, and other information required to
34operate the treatment equipment in a safe and effective manner.
35begin deleteAnnual refresherend delete

36begin insert(2)end insertbegin insertend insertbegin insertAnnualend insert training for the operators shall be provided after the
37initial training has been completed.begin delete Theend delete

38begin insert(3)end insertbegin insertend insertbegin insertTheend insert training shall be documented for each treatment operator
39and retained on file at the generator facility for a minimum of two
40years.begin insert Training shall comply with applicable federal Occupational
P22   1Safety and Health Administration regulations, including those
2found in Section 1910 of Title 29 of the Code of Federal
3Regulations.end insert

4

begin deleteSEC. 47.end delete
5begin insertSEC. 42.end insert  

Section 117940 of the Health and Safety Code is
6amended to read:

7

117940.  

(a) Each enforcement agency shall follow procedures
8consistent with this chapter in registering medical waste generators.

9(b) Each medical waste generator registration for small quantity
10generators issued by the enforcement agency shall be valid for two
11years.

12(c) An application for renewal of the registration for small
13quantity generators shall be filed with the enforcement agency on
14or before the expiration date.

15(d) Generators shall submitbegin delete within 30 daysend delete an updated
16application form when any of the information specified in their
17medical waste management planbegin insert, created pursuant to Section
18117935,end insert
changes.begin insert The updated application form shall be submitted
19within 30 days of the change.end insert

20

begin deleteSEC. 48.end delete
21begin insertSEC. 43.end insert  

Section 117943 of the Health and Safety Code is
22amended to read:

23

117943.  

begin insert(a)end insertbegin insertend insertA medical waste generator required to register
24pursuant to this chapter shall maintain for a minimum of two years
25individual treatment operating records, and if applicable, shipping
26documents for all untreated medical waste shipped offsite for
27treatment, and shall report or submit to the enforcement agency,
28upon request, all of the following:

begin delete

26 29(a)

end delete

30begin insert(1)end insert Treatment operating records. Operating records shall be
31maintained in written or electronic form.

begin delete

28 32(b)

end delete

33begin insert(2)end insert An emergency action plan complying with regulations
34adopted by the department.

begin delete

30 35(c)

end delete

36begin insert(3)end insert Shipping documents or electronically archived shipping
37documents maintained by the facility or medical waste hauler of
38all untreated medical waste shipped offsite for treatment.

begin delete

33 39(d)

end delete

P23   1begin insert(b)end insert Documentation shall be made available to the enforcement
2agency onsite as soon as feasible, but no more than two business
3days following the request.

4

begin deleteSEC. 49.end delete
5begin insertSEC. 44.end insert  

Section 117945 of the Health and Safety Code is
6amended to read:

7

117945.  

begin insert(a)end insertbegin insertend insert Small quantity generators who are not required
8to register pursuant to this chapter shall maintain on file in their
9office all of following:

begin delete

P21 1 10(a)

end delete

11begin insert(1)end insert An information document stating how the generator contains,
12stores, treats, and disposes of any medical waste generated through
13any act or process of the generator.

begin delete

4 14(b)

end delete

15begin insert(2)end insert Records required by the United States Department of
16Transportation or the United States Postal Service of any medical
17waste shipped offsite for treatment and disposal. The small quantity
18generator shall maintain, or have available electronically at the
19facility or from the medical waste hauler or common carrier, these
20records, for not less than two years.

begin delete

10 21(c)

end delete

22begin insert(b)end insert Documentation shall be made available to the enforcement
23agency onsite as soon as feasible, but no more than two days
24following the request.

25

begin deleteSEC. 50.end delete
26begin insertSEC. 45.end insert  

Section 117946 is added to the Health and Safety
27Code
, to read:

28

117946.  

(a) A small quantity medical waste generator or parent
29organization that employs health care professionals who generate
30medical waste may transport medical waste generated in limited
31quantities to the central location of accumulation, provided that
32all of the following are met:

33(1) The principal business of the generator is not to transport
34or treat regulated medical waste.

35(2) The generator shall adhere to the conditions and requirements
36set forth in the materials of trade exception, as specified in Section
37173.6 of Title 49 of the Code of Federal Regulations.

38(3) A person transporting medical waste pursuant to this section
39shall provide a form or log to the receiving facility, and the
P24   1receiving facility shall maintain the form or log for a period of two
2years, containing all of the following information:

3(A) The name of the person transporting the medical waste.

4(B) The number of containers of medical waste transported.

5(C) The date the medical waste was transported.

6(b) A generator transporting medical waste pursuant to this
7section shall not be regulated as a hazardous waste hauler pursuant
8to Section 117660.

9

begin deleteSEC. 51.end delete
10begin insertSEC. 46.end insert  

Section 117950 of the Health and Safety Code is
11amended to read:

12

117950.  

(a) Each large quantity generator, except as specified
13in subdivisions (b) and (c), shall register with the enforcement
14agency prior to commencement of the generation of medical waste.

15(b) Large quantity generators operating as a business in the same
16building, or that are associated with a group practice in the same
17building, may register as one generator.

18(c) Large quantity generators as specified in subdivision (a),
19operating in different buildings on the same or adjacent property,
20or as approved by the enforcement agency, may register as one
21generator.

22(d) “Adjacent,” for purposes of subdivision (c), means real
23property within 400 yards from the property boundary of the
24primary registration site. All federal transportation requirements
25specified in Section 173.6 of Part 49 of the Code of Federal
26Regulations shall apply for purposes of transporting medical waste
27from adjacent properties.

28

begin deleteSEC. 52.end delete
29begin insertSEC. 47.end insert  

Section 117955 of the Health and Safety Code is
30repealed.

31

begin deleteSEC. 53.end delete
32begin insertSEC. 48.end insert  

Section 117960 of the Health and Safety Code is
33amended to read:

34

117960.  

begin deleteAny end deletebegin insertA end insertlarge quantity generator required to register
35with the enforcement agency shall file with the enforcement agency
36a medical waste management planbegin delete containing, butend deletebegin insert, on forms
37prescribed by the enforcement agency, if provided. The plans shall
38containend insert
begin insert, butend insertbegin insert areend insert not limited to, all of the following:

39(a) The name of the person.

40(b) The business address of the person.

P25   1(c) The type of business.

2(d) The types, and the estimated average monthly quantity, of
3medical waste generated.

4(e) The type of treatment used onsite, if applicable. For
5generators with onsite medical waste treatment facilities, the
6treatment capacity of the onsite treatment facility.

7(f) The name and business address of the registered hazardous
8waste hauler used by the generator to have untreated medical waste
9removed for treatment, if applicable, and, if applicable, the name
10and business address of the common carrier transporting
11pharmaceutical waste pursuant to Section 118032.

12(g) The name and business address of the offsite medical waste
13treatment facility to which the medical waste is being hauled, if
14applicable.

15(h) An emergency action plan complying with regulations
16adopted by the department.

17(i) If applicable, the steps taken to categorize the pharmaceutical
18wastes generated at the facility to ensure that the wastes are
19properly disposed of as follows:

20(1) Pharmaceutical wastes classified by the federal Drug
21Enforcement Agency (DEA) as “controlled substances” are
22 disposed of in compliance with DEA requirements.

23(2) The name and business address of the hazardous waste hauler
24used by the generator to have wastes that are not regulated pursuant
25to the federal Resource Conservation and Recovery Act of 1976
26and nonradioactive pharmaceutical wastes regulated as medical
27wastes safely removed for treatment in compliance with subdivision
28(b) of Section 118222, as waste requiring specific methods.

29(j) A closure plan for the termination of treatment at the facility
30begin insert using, at a minimum, one of the methods of decontamination
31specified in subdivision (a) or (b) of Section 118295, thereby
32rendering the property to an acceptable sanitary condition
33following the completion of treatment services at the siteend insert
.

34(k) A statement certifying that the information provided is
35complete and accurate.

36

begin deleteSEC. 54.end delete
37begin insertSEC. 49.end insert  

Section 117967 is added to the Health and Safety
38Code
, to read:

39

117967.  

begin insert(a)end insertbegin insertend insert Large quantity generators that treat medical waste
40onsite using steam sterilization, incineration, microwave
P26   1technology, or other department approved treatment technology
2to treat medical waste shall train the operators of the equipment
3in its use, proper protective equipment to wear, if necessary, and
4how to clean up spills to ensure that the equipment is being
5operated in a safe and effective manner.begin delete Annual refresherend delete

6begin insert(b)end insertbegin insertend insertbegin insertAnnualend insert training for the operators shall be provided after the
7initial training has been completed.begin delete Theend delete

8begin insert(c)end insertbegin insertend insertbegin insertTheend insert training shall be documented and the documentation
9shall be retained at the facility for a minimum of two years.
10begin insert Training shall comply with applicable federal Occupational Safety
11and Health Administration regulations, including those found in
12Section 1910 of Title 29 of the Code of Federal Regulations.end insert

13

begin deleteSEC. 55.end delete
14begin insertSEC. 50.end insert  

Section 117970 of the Health and Safety Code is
15amended to read:

16

117970.  

(a) Each enforcement agency shall follow procedures
17consistent with this chapter in registering medical waste generators.

18(b) Each medical waste registration issued by the enforcement
19agency for large quantity generators shall be valid for one year.

20(c) An application for renewal of the registration shall be filed
21with the enforcement agency not less than 90 days prior to the
22expiration date. Failure to meet this requirement shall result in an
23assessment of a late fee.

24(d) Generators shall update their medical waste management
25planbegin delete within 30 daysend deletebegin insert, established pursuant to Section 117960,end insert when
26any of the information in begin deletetheir medical waste managementend delete begin insert theend insert plan
27changes and shall have the plan on file for review during an
28inspection or upon request.begin insert The updated plan shall be submitted
29within 30 days of the change.end insert

30

begin deleteSEC. 56.end delete
31begin insertSEC. 51.end insert  

Section 117975 of the Health and Safety Code is
32repealed.

33

begin deleteSEC. 57.end delete
34begin insertSEC. 52.end insert  

Section 117975 is added to the Health and Safety
35Code
, to read:

36

117975.  

(a) A large quantity medical waste generator required
37to register pursuant to this chapter shall maintain for a minimum
38of two years individual treatment records and shipping documents
39for all untreated medical waste shipped offsite for treatment. The
P27   1generator shall report or submit to the enforcement agency, upon
2request, all of the following:

3(1) Treatment operating records. Operating records shall be
4maintained in written or electronic form.

5(2) An emergency action plan in accordance with regulations
6adopted by the department.

7(3) Shipping documents or electronically archived shipping
8 documents maintained by the facility or medical waste hauler of
9all untreated medical wastes shipped offsite for treatment.

10(b) Documentation shall be made available to the enforcement
11agency onsite as soon as feasible, but no more than two business
12days following the request.

13

begin deleteSEC. 58.end delete
14begin insertSEC. 53.end insert  

Section 117976 is added to the Health and Safety
15Code
, to read:

16

117976.  

(a) A large quantity medical waste generator or parent
17organization that employs health care professionals who generate
18medical waste may transport medical waste generated in limited
19quantities to the central location of accumulation, provided that
20all of the following are met:

21(1) The principal business of the generator is not to transport
22or treat regulated medical waste.

23(2) The generator shall adhere to the conditions and requirements
24set forth in the materials of trade exception, as specified in Section
25173.6 of Title 49 of the Code of Federal Regulations.

26(3) A person transporting medical waste pursuant to this section
27shall provide a form or log to the receiving facility, and the
28receiving facility shall maintain the form or log for a period of two
29years, containing all of the following information:

30(A) The name of the person transporting the medical waste.

31(B) The number of containers of medical waste transported.

32(C) The date the medical waste was transported.

33(b) A generator transporting medical waste pursuant to this
34section shall not be regulated as a hazardous waste hauler pursuant
35to Section 117660.

begin delete36

SEC. 59.  

Section 117980 of the Health and Safety Code is
37repealed.

end delete
begin delete38

SEC. 60.  

Section 117985 of the Health and Safety Code is
39repealed.

end delete
P28   1begin insert

begin insertSEC. 54.end insert  

end insert

begin insertSection 117985 of the end insertbegin insertHealth and Safety Codeend insertbegin insert is
2amended to read:end insert

3

117985.  

begin deleteTreatment of medical end deletebegin insertMedical end insertwaste shall bebegin insert treated
4using treatment technologies approvedend insert
in accordance with Chapter
58 (commencing with Section 118215).

6

begin deleteSEC. 61.end delete
7begin insertSEC. 55.end insert  

Section 117990 of the Health and Safety Code is
8amended to read:

9

117990.  

The fee schedule specified in Section 117995 shall be
10for the issuance of medical waste registrations and onsite medical
11waste treatment facility permits when the department serves as the
12enforcement agency for large quantity generators. This fee schedule
13shall be adjusted annually in accordance with Section 100425.
14Local enforcement agencies shall set fees that shall be sufficient
15to cover their costs in implementing this part with regard to large
16quantity generators.

17

begin deleteSEC. 62.end delete
18begin insertSEC. 56.end insert  

Section 118000 of the Health and Safety Code is
19amended to read:

20

118000.  

(a) Medical waste shall only be transported to a
21permitted medical waste treatment facility, or to a transfer station
22or another registered generator for the purpose of consolidation
23before treatment and disposal.

24(b) Facilities for the transfer of medical waste shall be annually
25inspected and issued permits in accordance with the regulations
26adopted pursuant to this part.

27(c) Medical waste transported out of state shall be consigned to
28a permitted medical waste treatment facility in the receiving state.
29If there is no permitted medical waste treatment facility in the
30receiving state or if the medical waste is crossing an international
31border, the medical waste shall be treated in accordance with
32 Chapter 8 (commencing with Section 118215) prior to being
33transported out of the state.

34

begin deleteSEC. 63.end delete
35begin insertSEC. 57.end insert  

Section 118005 of the Health and Safety Code is
36repealed.

37

begin deleteSEC. 64.end delete
38begin insertSEC. 58.end insert  

Section 118025 of the Health and Safety Code is
39amended to read:

P29   1

118025.  

All medical waste shall be hauled by a registered
2hazardous waste hauler, the United States Postal Service, or by a
3person with an exception granted pursuant to Section 117946 for
4small quantity generators or pursuant to Section 117976 for large
5quantity generators.

6

begin deleteSEC. 65.end delete
7begin insertSEC. 59.end insert  

Section 118027 of the Health and Safety Code is
8amended to read:

9

118027.  

A person who is authorized to collect solid waste, as
10defined in Section 40191 of the Public Resources Code, who
11unknowingly transports medical waste to a solid waste facility, as
12defined in Section 40194 of the Public Resources Code, incidental
13to the collection of solid waste, is exempt from the provisions of
14the Medical Waste Management Act with regard to that waste. If
15a solid waste transporter discovers that he or she has hauled
16untreated medical waste to a landfill or materials recovery facility,
17he or she shall contact the originating generator of the medical
18waste to respond to the landfill or recovery facility to provide
19ultimate proper disposal of the medical waste. The solid waste
20facility operator may, at its discretion and after contacting the
21generator, make arrangements for the proper treatment and disposal
22of the medical waste at a facility approved by the department. Title
23to the waste remains with the generator. Reimbursement costs for
24the proper management of discovered waste shall be the originating
25generator’s responsibility.

26

begin deleteSEC. 66.end delete
27begin insertSEC. 60.end insert  

Section 118029 of the Health and Safety Code is
28amended to read:

29

118029.  

(a) Haulers of medical waste in California, with the
30exception of those using a materials of trade exception as specified
31in Sections 117946 and 117976, and United States Department of
32Transportation licensed common carriers hauling pharmaceutical
33waste, shall meet all United States Department of Transportation
34requirements for transporting medical waste and shall be hazardous
35waste haulers in California. On or before July 1, of each year, a
36registered hazardous waste hauler that transports medical waste
37shall so notify the department, and provide, in a format that
38conforms to the protocol requirements for submission of data to
39the department, the following information:

40(1) Business name, address, and telephone number.

P30   1(2) Name of owner, operator, and contact person.

2(3) Hazardous waste transporter registration number.

3(4) The number of vehicles and trailers transporting medical
4waste within the state as of that date.

5(5) Types and quantities of medical waste collected, in pounds.

6(6) The names of the generators whose waste has been
7transported by the hauler and the amounts of medical waste
8transported, by waste type category.

9(b)  Each registered hazardous waste hauler shall provide to the
10department a list of all medical waste generators serviced by that
11person during the previous 12 months. That list shall include the
12business name, business address, mailing address, telephone
13number, and other information as required by the department to
14collect annual fees pursuant to Section 117924. The list shall be
15provided to the department within 10 days of the close of the
16earliest calendar quarter ending September 30, December 31,
17March 31, or June 30, or as otherwise required by the department.

18

begin deleteSEC. 67.end delete
19begin insertSEC. 61.end insert  

Section 118030 of the Health and Safety Code is
20repealed.

21

begin deleteSEC. 68.end delete
22begin insertSEC. 62.end insert  

Section 118032 of the Health and Safety Code is
23amended to read:

24

118032.  

A pharmaceutical waste generator or parent
25organization that employs health care professionals who generate
26pharmaceutical waste is exempt from the requirements of
27subdivision (a) of Section 118000 if all of the following
28requirements are met:

29(a) The generator or parent organization has on file one of the
30following:

31(1) If the generator or parent organization is a small quantity
32generator required to register pursuant to Chapter 4 (commencing
33with Section 117925), a medical waste management plan prepared
34pursuant to Section 117935.

35(2) If the generator or parent organization is a small quantity
36generator not required to register pursuant to Chapter 4
37 (commencing with Section 117925), the information document
38maintained pursuant to subdivision (a) of Section 117945.

P31   1(3) If the generator or parent organization is a large quantity
2generator, a medical waste management plan prepared pursuant
3to Section 117960.

4(b) The generator or health care professional who generated the
5pharmaceutical waste transports the pharmaceutical waste himself
6or herself, or directs a member of his or her staff to transport the
7pharmaceutical waste to a parent organization or another health
8care facility for the purpose of consolidation before treatment and
9disposal, or contracts with a common carrier to transport the
10pharmaceutical waste to a permitted medical waste treatment
11facility or transfer station.

12(c) Except as provided in subdivision (d), all of the following
13requirements are met:

14(1) Prior to shipment of the pharmaceutical waste, the generator
15notifies the intended destination facility that it is shipping
16pharmaceutical waste to it and provides a copy of the shipping
17document, as specified in Section 117770.

18(2) The generator and the facility receiving the pharmaceutical
19waste maintain the shipping document, as specified in Section
20117770.

21(3) The facility receiving the pharmaceutical waste notifies the
22generator of the receipt of the pharmaceutical waste shipment and
23any discrepancies between the items received and the shipping
24document, as specified in Section 117770, evidencing diversion
25of the pharmaceutical waste.

26(4) The generator notifies the enforcement agency of any
27discrepancies between the items received and the shipping
28document, as specified in Section 117770, evidencing diversion
29of the pharmaceutical waste.

30(d) (1) Notwithstanding subdivision (c), if a health care
31professional who generates pharmaceutical waste returns the
32pharmaceutical waste to the parent organization for the purpose
33of consolidation before treatment and disposal over a period of
34time, a single-page form or multiple entry log may be substituted
35for the tracking document, if the form or log contains all of the
36following information:

37(A) The name of the person transporting the pharmaceutical
38waste.

39(B) The number of containers of pharmaceutical waste. This
40clause does not require any generator to maintain a separate
P32   1pharmaceutical waste container for every patient or to maintain
2records as to the specified source of the pharmaceutical waste in
3any container.

4(C) The date that the pharmaceutical waste was returned.

5(2) The form or log described in paragraph (1) shall be
6maintained in the files of the health care professional who generates
7the pharmaceutical waste and the parent organization or another
8health care facility that receives the pharmaceutical waste.

9(3) This subdivision does not prohibit the use of a single
10document to verify the return of more than one container to a parent
11organization or another health care facility, provided the form or
12log meets the requirements specified in paragraphs (1) and (2).

13

begin deleteSEC. 69.end delete
14begin insertSEC. 63.end insert  

Section 118040 of the Health and Safety Code is
15repealed.

16

begin deleteSEC. 70.end delete
17begin insertSEC. 64.end insert  

Section 118045 of the Health and Safety Code is
18amended to read:

19

118045.  

(a) The department shall charge an application fee
20for a permit for a transfer station equal to one hundred dollars
21($100) for each hour which the department spends on processing
22the application, but not more than ten thousand dollars ($10,000).

23(b) In addition to the fee specified in subdivision (a), the annual
24permit fee for a transfer station is two thousand dollars ($2,000).

25

begin deleteSEC. 71.end delete
26begin insertSEC. 65.end insert  

Section 118135 of the Health and Safety Code is
27amended to read:

28

118135.  

Each person operating an offsite medical waste
29treatment facility shall obtain a permit pursuant to this chapter
30from the department prior to commencement of the treatment
31facility’s operation.

32

begin deleteSEC. 72.end delete
33begin insertSEC. 66.end insert  

Section 118150 of the Health and Safety Code is
34amended to read:

35

118150.  

Each enforcement agency shall follow procedures that
36are consistent with the Medical Waste Management Act and the
37regulations adopted pursuant to this chapter, when issuing medical
38waste permits.

P33   1

begin deleteSEC. 73.end delete
2begin insertSEC. 67.end insert  

Section 118155 of the Health and Safety Code is
3amended to read:

4

118155.  

A person required to obtain an offsite medical waste
5treatment facility permit pursuant to this part shall file with the
6enforcement agency an application containing, but not limited to,
7all of the following:

8(a) The name of the applicant.

9(b) The business address of the applicant.

10(c) The type of treatment provided, the treatment capacity of
11the facility, a characterization of the waste treated at this facility
12begin insert and the estimated average monthly quantity of waste treated at
13the facilityend insert
.

14(d) A disclosure statement, as provided in Section 25112.5,
15except for onsite medical waste treatment facilities.

16(e) A plan for closure of the facility usingbegin insert, at minimum,end insert one of
17the methods of decontamination specified in subdivision (a) or (b)
18of Section 118295, thereby rendering the property to an acceptable
19sanitary condition following the ending of treatment services at
20the site.

21(f) Any other information required by the enforcement agency
22for the administration or enforcement of this part or the regulations
23adopted pursuant to this part.

24

begin deleteSEC. 74.end delete
25begin insertSEC. 68.end insert  

Section 118160 of the Health and Safety Code is
26amended to read:

27

118160.  

(a) Prior to issuing or renewing a permit for an offsite
28medical waste treatment facility, the department shall review the
29compliance history of the applicant, under any local, state, or
30federal law or regulation governing the control of medical waste
31or pollution.

32(b) The department shall, pursuant to this section, deny a permit,
33or specify additional permit conditions, to ensure compliance with
34applicable regulations, if the department determines that in the
35three-year period preceding the date of application the applicant
36has violated laws or regulations identified in subdivision (a) at a
37facility owned or operated by the applicant, and the violations
38demonstrate a recurring pattern of noncompliance or pose, or have
39 posed, a significant risk to public health and safety or to the
40environment.

P34   1(c) In making the determination of whether to deny a permit or
2to specify additional permit conditions, the department shall take
3both of the following into consideration:

4(1) Whether a permit denial or permit condition is appropriate
5or necessary given the severity of the violation.

6(2) Whether the violation has been corrected in a timely fashion.

7

begin deleteSEC. 75.end delete
8begin insertSEC. 69.end insert  

Section 118205 of the Health and Safety Code is
9amended to read:

10

118205.  

The fee schedule specified in Section 118210 shall
11cover the issuance of medical waste treatment facility permits and
12an inspection program, when the department serves as the
13enforcement agency. This fee schedule shall be adjusted annually
14in accordance with Section 100425. The department may adjust
15by regulation the fees specified in Section 118210 to reflect the
16actual costs of implementing this chapter. Local enforcement
17agencies shall set fees that shall be sufficient to cover their costs
18in implementing this part with regard to large quantity generators.

19

begin deleteSEC. 76.end delete
20begin insertSEC. 70.end insert  

Section 118215 of the Health and Safety Code is
21amended to read:

22

118215.  

(a) Except as provided in subdivisions (b) and (c), a
23person generating or treating medical waste shall ensure that the
24medical waste is treated by one of the following methods, thereby
25rendering it solid waste, as defined in Section 40191 of the Public
26Resources Code, prior to disposal:

27(1) (A) Incineration at a permitted medical waste treatment
28facility in a controlled-air, multichamber incinerator, or other
29method of incineration approved by the department which provides
30complete combustion of the waste into carbonized or mineralized
31ash.

32(B) Treatment with an alternative technology approved pursuant
33to paragraph (3), which, due to the extremely high temperatures
34of treatment in excess of 1300 degrees Fahrenheit, has received
35express approval from the department.

36(2) Steam sterilization at a permitted medical waste treatment
37facility or by other sterilization, in accordance with all of the
38following operating procedures for steam sterilizers or other
39sterilization:

P35   1(A) Standard written operating procedures shall be established
2for biological indicators, or for other indicators of adequate
3sterilization approved by the department, for each steam sterilizer,
4including time, temperature, pressure, type of waste, type of
5container, closure on container, pattern of loading, water content,
6and maximum load quantity.

7(B) Recording or indicating thermometers shall be checked
8during each complete cycle to ensure the attainment of 121°
9Centigrade (250° Fahrenheit) for at least one-half hour, depending
10on the quantity and density of the load, to achieve sterilization of
11the entire load. Thermometers, thermocouples, or other monitoring
12devices identified in the facility operating plan shall be checked
13for calibration annually. Records of the calibration checks shall
14be maintained as part of the facility’s files and records for a period
15of two years or for the period specified in the regulations.

16(C) Heat-sensitive tape, or another method acceptable to the
17enforcement agency, shall be used on each biohazard bag or sharps
18container that is processed onsite to indicate that the waste went
19through heat treatment. If the biohazard bags or sharps containers
20are placed in a large liner bag within the autoclave for treatment,
21heat-sensitive tape or another method acceptable to the enforcement
22agency only needs to be placed on the liner bag and not on every
23hazardous waste bag or sharps container being treated.

24(D) The biological indicator Geobacillus stearothermophilus,
25or other indicator of adequate sterilization as approved by the
26department, shall be placed at the center of a load processed under
27standard operating conditions at least monthly to confirm the
28attainment of adequate sterilization conditions.

29(E) Records of the procedures specified in subparagraphs (A),
30(B), and (D) shall be maintained for a period of not less than two
31years.

32(3) (A) Other alternative medical waste treatment methods
33which are both of the following:

34(i) Approved by the department.

35(ii) Result in the destruction of pathogenic micro-organisms.

36(B) Any alternative medical waste treatment method proposed
37to the department shall be evaluated by the department and either
38approved or rejected pursuant to the criteria specified in this
39subdivision.

P36   1(b) Fluid blood or fluid blood products may be discharged to a
2public sewage system without treatment if its discharge is
3consistent with waste discharge requirements placed on the public
4sewage system by the California regional water quality control
5board with jurisdiction.

6(c) (1) A medical waste that is a biohazardous laboratory waste,
7as defined inbegin insert subparagraph (B) of paragraph (1) of subdivision
8(b) ofend insert
Section 117690, may be treated by a chemical disinfection
9if the waste is liquid or semiliquid and the chemical disinfection
10method is recognized by the National Institutes of Health, the
11Centers for Disease Control and Prevention, or the American
12Biological Safety Association, and if the use of chemical
13disinfection as a treatment method is identified in the site’s medical
14waste management plan.

15(2) If the waste is not treated by chemical disinfection, in
16accordance with paragraph (1), the waste shall be treated by one
17of the methods specified in subdivision (a).

18(3) Following treatment by chemical disinfection, the medical
19waste may be discharged to the public sewage system if the
20discharge is consistent with waste discharge requirements placed
21on the public sewage system by the California regional water
22control board, and the discharge is in compliance with the
23requirements imposed by the owner or operator of the public
24sewage system. If the chemical disinfection of the medical waste
25causes the waste to become a hazardous waste, the waste shall be
26managed in accordance with the requirements of Chapter 6.5
27(commencing with Section 25100) of Division 20.

28

begin deleteSEC. 77.end delete
29begin insertSEC. 71.end insert  

Section 118220 of the Health and Safety Code is
30amended to read:

31

118220.  

Pathologybegin delete waste, with the exception of teethend deletebegin insert waste of
32a human nature, as defined in subparagraph (A) of paragraph (2)
33of subdivision (b) of Section 117690end insert
, shall be disposed of by
34interment, incineration, or alternative treatment technologies
35approved to treat this type of wastebegin insert, pursuant to paragraph (1) or
36paragraph (3) of subdivision (a) of Section 118215end insert
.

37

begin deleteSEC. 78.end delete
38begin insertSEC. 72.end insert  

Section 118222 of the Health and Safety Code is
39amended to read:

P37   1

118222.  

(a) Pathology waste that meets the conditions of
2paragraph (2) of subdivision (b) of Section 117690 and trace
3chemotherapy waste that meets the conditions of paragraph (5) of
4subdivision (b) of Section 117690 shall be treated by incineration
5or alternative treatment technologies approved to treat that waste
6pursuant to paragraph (1) or paragraph (3) of subdivision (a) of
7Section 118215 prior to disposal.

8(b) Pharmaceutical waste from health care settings that meets
9the conditions specified in paragraph (3) of subdivision (b) of
10Section 117690 shall be treated by incineration or alternative
11treatment technologies approved to treat that waste pursuant to
12paragraph (1) or paragraph (3) of subdivision (a) of Section 118215
13prior to disposal.

14

begin deleteSEC. 79.end delete
15begin insertSEC. 73.end insert  

Section 118240 of the Health and Safety Code is
16amended to read:

17

118240.  

Notwithstanding Section 9141 of the Food and
18Agricultural Code, animals that die from infectious diseases or
19that are euthanized because they are suspected of having been
20exposed to infectious disease shall be treated with a treatment
21technology approved by the department for that use if, in the
22opinion of the attending veterinarian or local health officer, the
23carcass presents a danger of infection to humans.

24

begin deleteSEC. 80.end delete
25begin insertSEC. 74.end insert  

Section 118245 of the Health and Safety Code is
26amended to read:

27

118245.  

The department shall charge an application fee for
28evaluation of an alternative treatment technology of two thousand
29five hundred dollars ($2,500) and shall charge an additional fee
30equal to one hundred dollars ($100) per hour for each hour which
31the department spends on processing the application, but not more
32than a total of five thousand dollars ($5,000).

33

begin deleteSEC. 81.end delete
34begin insertSEC. 75.end insert  

Section 118275 of the Health and Safety Code is
35amended to read:

36

118275.  

(a) To containerize or store medical waste, at the
37point of generation and while collected in that room, a person shall
38do all of the following:

39(1) Medical waste, as defined in Section 117690, shall be
40contained separately from other waste at the point of origin in the
P38   1producing facility. Sharps containers may be placed in biohazard
2bags or in containers with biohazard bags.

3(2) Biohazardous waste, as defined in paragraph (1) of
4subdivision (b) of Section 117690, shall be placed in abegin delete redend delete
5 biohazard bag conspicuously labeled with the words “Biohazardous
6Waste” or with the international biohazard symbol and the word
7“BIOHAZARD.”

8(3) Sharps waste, as defined in paragraph (4) of subdivision (b)
9of Section 117690, including sharps and pharmaceutical waste
10containerized pursuant to paragraph (7), shall be contained in a
11United States Food and Drug Administration (USFDA) approved
12sharps container that meets USFDA labeling requirements and is
13handled pursuant to Section 118285.

14(4) Trace chemotherapy waste, as defined in paragraph (5) of
15subdivision (b) of Section 117690, shall be segregated for storage,
16and, when placed in a secondary container, that container shall be
17labeled with the words “Chemotherapy Waste,” “CHEMO,” or
18other label approved by the department on the sides, so as to be
19visible from any lateral direction, to ensure treatment of the
20biohazardous waste pursuant to Section 118222. Sharps waste that
21is contaminated through contact with, or having previously
22contained, chemotherapeutic agents, shall be placed in sharps
23containers labeled in accordance with the industry standard with
24the words “Chemotherapy Waste,” “Chemo,” or other label
25approved by the department, and shall be segregated to ensure
26treatment of the sharps waste pursuant to Section 118222.

27(5)  Pathology waste, as defined in paragraph (2) of subdivision
28(b) of Section 117690, shall be segregated for storage and, when
29placed in a secondary container, that container shall be labeled
30with the words “Pathology Waste,” “PATH,” or other label
31approved by the department on the sides, so as to be visible from
32any lateral direction, to ensure treatment of the waste pursuant to
33Section 118222.

34(6) Pharmaceutical waste, as defined in paragraph (3) of
35subdivision (b) of Section 117690, shall be segregated for storage
36in accordance with the facility’s medical waste management plan
37to ensure that it is properly containerized for disposal in compliance
38with United States Department of Transportation and United States
39Drug Enforcement Agency (DEA) requirements.

P39   1(A) Pharmaceutical wastes classified by the DEA as “controlled
2substances” shall be disposed of in compliance with DEA
3requirements.

4(B) Nonradioactive pharmaceutical wastes that are not subject
5to the federal Resource Conservation and Recovery Act of 1976
6(Public Law 94-580), as amended, and that are regulated as medical
7waste are placed in a container or secondary container labeled with
8the words “INCINERATION ONLY,” “PHARMACEUTICAL”
9or other label approved by the department on the sides, so as to be
10visible from any lateral direction, to ensure treatment of the
11biohazardous waste pursuant to Section 118222.

12(7) A person may consolidate into a common container, which
13may be reusable, sharps waste, as defined in paragraph (4) of
14subdivision (b) of Section 117690, and pharmaceutical wastes, as
15defined in paragraph (3) subdivision (b) of Section 117690,
16provided that the consolidated waste isbegin delete treatedend deletebegin insert incineratedend insert pursuant
17to paragraph (1) of subdivision (a) of Section 118215 and the
18container meets the requirements of Section 118285. The container
19shall be labeled with the biohazardous waste symbol and the words
20“HIGH HEAT ONLY,” “INCINERATION,” or other label
21approved by the department on the sides, so as to be visible from
22any lateral direction, to ensure treatment of the waste pursuant to
23this subdivision.

24(b) To containerize medical waste being held for shipment
25offsite for treatment, the waste shall be labeled, as outlined in
26subdivision (a), on the sides of the container.

27(c) When medical waste is containerized pursuant to
28subdivisions (a) and (b) there is no requirement to label the
29containers with the date that the waste started to accumulate.

30

begin deleteSEC. 82.end delete
31begin insertSEC. 76.end insert  

Section 118280 of the Health and Safety Code is
32amended to read:

33

118280.  

To containerize biohazard bags, a person shall do all
34of the following:

35(a) The bags shall be tied to prevent leakage or expulsion of
36contents during all future storage, handling, or transport in
37compliance with United States Department of Transportation
38requirements.

39(b) (1) Medical waste may be placed into a biohazard bag and
40tied, as required in subdivision (a), in a patient room and shall be
P40   1immediately transported upon completion of the procedure directly
2from the point of generation and placed into a biohazard container
3stored in a soiled utility room or other biohazardous waste storage
4area without having first been placed into a secondary container
5in the patient room.

6(2) Medical waste may be placed into a biohazard bag hung on
7a hamper stand in a surgery suite and the bag removed from the
8hamper stand after completion of the procedure, taken out of the
9surgery suite, and placed into a biohazard container stored in a
10soiled utility room or other biohazard waste storage area.

11(c) Biohazardous waste, except as provided in subdivision (b),
12shall be bagged in accordance with subdivision (b) of Section
13118275 and placed for storage, handling, or transport in a rigid
14container that may be disposable, reusable, or recyclable.
15Containers shall be leak resistant, have tight-fitting covers, and be
16kept clean and in good repair. Containers may be recycled with
17the approval of the enforcement agency. Containers may be of any
18color and shall be labeled with the words “Biohazardous Waste”
19or with the international biohazard symbol and the word
20“BIOHAZARD” on the sides so as to be visible from any lateral
21direction. Containers shall comply with United States Department
22of Transportation requirements.

23(d) Biohazardous waste shall not be removed from the biohazard
24bag until treatment as prescribed in Chapter 8 (commencing with
25Section 118215) is completed, except to eliminate a safety hazard,
26or by the enforcement officer in performance of an investigation
27pursuant to Section 117820. Biohazardous waste shall not be
28disposed of before being treated as prescribed in Chapter 8
29(commencing with Section 118215).

30(e) (1) Except as provided in paragraph (5), a person generating
31biohazardous waste shall comply with the following requirements:

32(A) If the person generates 20 or more pounds of biohazardous
33waste per month, the person shall not contain or store that waste
34above 0° Centigrade (32° Fahrenheit) at an onsite location for more
35than seven days without obtaining prior written approval of the
36enforcement agency.

37(B) If a person generates less than 20 pounds of biohazardous
38waste per month, the person shall not contain or store that waste
39above 0° Centigrade (32° Fahrenheit) at an onsite location for more
40than 30 days.

P41   1(2) A person may store biohazardous waste at or below 0°
2Centigrade (32° Fahrenheit) at an onsite location for not more than
390 days without obtaining prior written approval of the enforcement
4agency.

5(3) A person may store biohazardous waste at a permitted
6transfer station at or below 0° Centigrade (32° Fahrenheit) for not
7more than 30 days without obtaining prior written approval of the
8enforcement agency. A transfer station that does not have storage
9capacity at or below 0° Centigrade (32° Fahrenheit) may only store
10waste for a maximum of three days without obtaining prior written
11approval of the enforcement agency.

12(4) A person shall not store biohazardous waste above 0°
13Centigrade (32° Fahrenheit) at a location or facility that is offsite
14from the generator for more than seven days before treatment.

15(5) Notwithstanding paragraphs (1) to (4), inclusive, if the odor
16from biohazardous or sharps waste stored at a facility poses a
17nuisance, the enforcement agency may require more frequent
18removal.

19(f) Waste that meets the definition of pharmaceutical waste in
20paragraph (3) of subdivision (b) of Section 117690 shall not be
21subject to the limitations on storage time prescribed in subdivision
22(e). A person may store that pharmaceutical waste at an onsite
23location for not longer than 90 days when the container is ready
24for disposal, unless prior written approval from the enforcement
25agency is obtained. The container shall be emptied at least once
26per year, unless prior written approval from the enforcement agency
27is obtained. A person may store that pharmaceutical waste at a
28permitted transfer station for not longer than 30 days without
29obtaining prior written approval from the enforcement agency. A
30person shall not store pharmaceutical waste at a location or facility
31that is offsite from the generator for more than 30 days before
32treatment.

33(g) The containment and storage time for wastes consolidated
34in a common container pursuant to paragraph (7) of subdivision
35(a) of Section 118275 shall not exceed the storage time for any
36category of waste set forth in this section.

37

begin deleteSEC. 83.end delete
38begin insertSEC. 77.end insert  

Section 118286 of the Health and Safety Code is
39amended to read:

P42   1

118286.  

(a) A person shall not knowingly place
2home-generated sharps waste in any of the following containers:

3(1) Any container used for the collection of solid waste,
4recyclable materials, or greenwaste.

5(2) Any container used for the commercial collection of solid
6waste or recyclable materials from business establishments.

7(3) Any roll-off container used for the collection of solid waste,
8construction, and demolition debris, greenwaste, or other recyclable
9materials.

10(b) Home-generated sharps waste shall be transported only in
11a sharps container, or other containers approved by the enforcement
12agency, and shall only be managed at any of the following:

13(1) A household hazardous waste facility pursuant to Section
1425218.13.

15(2) A “home-generated sharps consolidation point” as defined
16in subdivision (b) of Section 117904.

17(3) A medical waste generator’s facility pursuant to Section
18118147.

19(4) A facility through the use of a medical waste mail-back
20container approved by the United States Postal Service.

21

begin deleteSEC. 84.end delete
22begin insertSEC. 78.end insert  

Section 118307 of the Health and Safety Code is
23amended to read:

24

118307.  

Medical waste that is stored in an area prior to transfer
25to the designated accumulation area, as defined in Section 118310,
26shall be stored in an area that is either locked or under direct
27supervision or surveillance. Intermediate storage areas shall be
28marked with the international biohazard symbol or the signage
29described in Section 118310. These warning signs shall be readily
30legible from a distance of five feet. This section does not apply to
31the rooms in which medical waste is generated.

32

begin deleteSEC. 85.end delete
33begin insertSEC. 79.end insert  

Section 118321.1 of the Health and Safety Code is
34amended to read:

35

118321.1.  

(a) A trauma scene waste management practitioner
36shall register with the department on forms provided by the
37department.

38(b) The department shall register a trauma scene waste
39management practitioner and issue a trauma scene waste hauling
40permit to a trauma scene waste management practitioner who
P43   1submits a completed application form and the registration fee,
2upon approval of the application by the department.

3(c) A registered trauma scene waste management practitioner
4is exempt from the registration requirements imposed pursuant to
5Chapter 6 (commencing with Section 118025) or Article 6.5
6(commencing with Section 25167.1) of Chapter 6.5 of Division
720 upon haulers of medical waste.

8(d) Registered trauma scene waste management practitioners
9shall pay an annual fee of two hundred dollars ($200) to the
10department for deposit in the fund. The fee revenues deposited in
11the fund pursuant to this subdivision may be expended by the
12department, upon appropriation by the Legislature, for the
13implementation of this chapter.

14

begin deleteSEC. 86.end delete
15begin insertSEC. 80.end insert  

Section 118321.5 of the Health and Safety Code is
16amended to read:

17

118321.5.  

(a) Trauma scene waste shall be removed from the
18trauma scene immediately upon completion of the removal phase
19of a trauma scene waste removal operation.

20(b) Trauma scene waste shall be transported to a permitted
21medical waste transfer station or treatment facility pursuant to the
22conditions and requirements set forth in the materials of trade
23exception specified in Section 173.6 of Title 49 of the Code of
24Federal Regulations, or may be stored in a dedicated freezer at the
25business location of the trauma scene waste management
26practitioner for a period of not more than 14 days, or as otherwise
27approved by the department.

28

begin deleteSEC. 87.end delete
29begin insertSEC. 81.end insert  

Section 118335 of the Health and Safety Code is
30amended to read:

31

118335.  

(a) In order to carry out the purpose of this part, any
32authorized representative of the enforcement agency may do any
33of the following:

34(1) Enter and inspect a facility for which a medical waste permit
35or registration has been issued, for which a medical waste permit
36or registration application has been filed, or that is subject to
37registration or permitting requirements pursuant to this part. Enter
38and inspect a vehicle for which a hazardous waste hauler
39registration has been issued, for which an application has been
P44   1filed for a hazardous waste hauler registration, or that is subject
2to registration requirements pursuant to this part.

3(2) Inspect and copy any records, reports, test results, or other
4information related to the requirements of this part or the
5regulations adopted pursuant to this part.

6(b) The inspection shall be made with the consent of the owner
7or possessor of the facilities or, if consent is refused, with a warrant
8duly issued pursuant to Title 13 (commencing with Section
91822.50) of Part 3 of the Code of Civil Procedure. However, in
10the event of an emergency affecting the public health or safety, an
11inspection may be made without consent or the issuance of a
12warrant.

13(c) Any traffic officer, as defined in Section 625 of the Vehicle
14Code, and any peace officer, as defined in Section 830.1 or 830.2
15of the Penal Code, may enforce Chapter 6 (commencing with
16Section 118000) and this chapter, and for purposes of enforcing
17these chapters, traffic officers and these peace officers are
18authorized representatives of the department.

19

begin deleteSEC. 88.end delete
20begin insertSEC. 82.end insert  

Section 118345 of the Health and Safety Code is
21amended to read:

22

118345.  

(a) Any person who intentionally makes any false
23statement or representation in any application, label, shipping
24document, record, report, permit, registration, or other document
25filed, maintained, or used for purposes of compliance with this
26part that materially affects the health and safety of the public is
27liable for a civil penalty of not more than ten thousand dollars
28($10,000) for each separate violation or, for continuing violations,
29for each day that the violation continues.

30(b) Any person who fails to register or fails to obtain a medical
31waste permit in violation of this part, or otherwise violates any
32provision of this part, any order issued pursuant to Section 118330,
33or any regulation adopted pursuant to this part, is liable for a civil
34penalty of not more than ten thousand dollars ($10,000) for each
35violation of a separate provision of this part or, for continuing
36violations, for each day that the violation continues.

37

begin deleteSEC. 89.end delete
38begin insertSEC. 83.end insert  

No reimbursement is required by this act pursuant to
39Section 6 of Article XIII B of the California Constitution because
40the only costs that may be incurred by a local agency or school
P45   1district will be incurred because this act creates a new crime or
2infraction, eliminates a crime or infraction, or changes the penalty
3for a crime or infraction, within the meaning of Section 17556 of
4the Government Code, or changes the definition of a crime within
5the meaning of Section 6 of Article XIII B of the California
6Constitution.



O

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