Amended in Senate August 22, 2014

Amended in Senate August 20, 2014

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, 117780, 117805, 117820, 117835, 117885, 117890, 117900, 117903, 117904, 117918, 117920, 117924, 117928, 117935,117938, 117940, 117943, 117945, 117950, 117960, 117970, 117985, 117990, 118000, 118025, 118027, 118029, 118032,begin insert 118040,end insert118045, 118135, 118150, 118155, 118160, 118205, 118215, 118220, 118222, 118240, 118245, 118275, 118280, 118286, 118307, 118321.1,begin insert 118321.5,end insert118335, and 118345 of, to add Sections 117636, 117647,begin insert 117771,end insert117946, 117967, and 117976 to, to repeal Sections 117620, 117635, 117748, 117755, 117777, 117933, 117955,118005,begin delete 118030, and 118040end deletebegin insert and 118030end insertof, and to repeal and add Sections 117630, 117690, 117750,begin delete 117770,end delete117895, 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,” “sharps container,” “tracking 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 deleteThis 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 would delete or recast provisions of the act that are inconsistent with that authority. The end deletebegin insertThe bill would require the State Department of Public Health to submit a report to the Legislature by no later than January 1, 2016, describing the interaction of federal and state law for the transport of regulated medical waste and would require the department to convene a stakeholder group for that purpose. The bill would authorize the department to update standards related to the transportation of medical waste during transport through a guidance document, as specified. The bill would authorize the department to temporarily waive the transportation requirements of this bill while a federal preemption determination is pending, as specified. The bill would provide that during this period of temporary waiver, or if federal preemption is found, the federal requirements would be deemed to be the law of this state and enforceable by the department.end insert

begin insert Thisend insert bill would also redefinebegin delete theend delete specified terms for purposes of thebegin delete Medical Waste Management Act,end deletebegin insert act,end insert including those above, and add definitions ofbegin insert newend insert terms, includingbegin delete aend deletebegin insert shipping document andend insert chemotherapeutic agent. The bill would include all subsets of waste in the definition of treatment. The bill would also authorize the color coding of biohazard bags, as specified.

(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 thebegin delete Medical Waste Management Act,end deletebegin insert act,end insert 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 agency and requires small quantity generators to register with the local enforcement agency.

This bill would authorize a registered large quantity or small quantity medical waste generator to generate medical waste at a temporary event, including vaccination clinics, and would require the large quantity or small quantity generator to notify the enforcement agency of its participation at such an event at least 72 hours before the event, except as provided.

(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 make various changes to the provisions relating to medical waste haulers, including removing provisions that conflict with the United States Department of Transportation regulation of those entities, authorizing a registered trauma scene waste practitioner, as specified, to haul medical waste, 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 shippingbegin insert and trackingend insert documents.

(5) Existing law exempts from specified provisions of thebegin delete Medical Waste Management Actend deletebegin insert act,end insert 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:

begin delete
3

117605.  

(a) The 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. Nothing
13in this part shall prohibit the department from using the formal
14administrative process provided by USDOT for adjudicating state
15preemption issues.

end delete
16begin insert

begin insert117605.end insert  

end insert
begin insert

(a) This part governs medical waste management at
17the facility where waste is generated, at transfer stations, and at
18treatment facilities. This part also governs the tracking of medical
19waste beyond what is required in federal shipping documents and
20regulates aspects of the transport of regulated medical waste.

end insert
begin insert

21(b) Sections 173.196 and 173.197 of Title 49 of the Code of
22Federal Regulations impose standards for the transportation of
23medical waste on public roads and highways while in transport,
24unless an affected person applies to, and receives a determination
25of any perceived conflict from, the United States Secretary of
26Transportation. Domestic Mail Manual 601.10.17.5 (Mailability:
27Hazardous Materials: Sharps and Other Mailable Regulated
28Medical Waste) imposes standards for the transportation of
P6    1medical waste through the mail and approves medical waste mail
2back systems.

end insert
begin insert

3(c) The department shall submit to the Legislature by no later
4than January 1, 2016, a report describing the interaction of federal
5and state law for the transport of regulated medical waste. The
6department shall convene a stakeholder group that includes, but
7is not limited to, small and large quantity generators, haulers,
8transfer station operators, treatment facility operators, local
9enforcement agencies, retailers, and other affected entities for this
10purpose. The reporting requirement imposed by this subdivision
11shall expire as of January 1, 2016, or when the report is submitted
12to the Legislature. The report submitted pursuant to this section
13shall be submitted in compliance with Section 9795 of the
14Government Code.

end insert
begin insert

15(d) The department may, in its discretion, update standards
16related to the transportation of medical waste during transit
17through a guidance document provided to regulated entities and
18posted on the department’s Internet Web site. This guidance
19document shall be exempt from the Administrative Procedure Act
20(Chapter 3.5 (commencing with Section 11340) of Part 1 of
21Division 3 of Title 2 of the Government Code) to the extent that
22the department finds that the updated standards are consistent
23with the standards of the United States Department of
24Transportation.

end insert
begin insert

25(e) If an affected person, including the department, seeks a
26preemption determination pursuant to Section 5125 of Title 49 of
27the United States Code or by a court of competent jurisdiction, the
28department may, in its discretion, temporarily waive the state
29transportation requirements under this part until that determination
30is made and shall provide notice of the waiver on its Internet Web
31site.

end insert
begin insert

32(f) During the period of temporary waiver described in
33subdivision (e), or if preemption is found, the federal requirements
34shall be deemed to be the law of this state and enforceable by the
35department. The department may enforce these federal
36requirements by providing an updated guidance document to
37interested parties and posting the updated guidance document on
38the department’s Internet Web site.

end insert
begin delete

39(b)

end delete

P7    1begin insert(g)end insert The Medical Waste Management Act does not preempt any
2local ordinance regulating infectious waste, as that term was
3defined by Section 25117.5 as it read on December 31, 1990, if
4the ordinance was in effect on January 1, 1990, and regulated both
5large and small quantity generators. Any ordinance may be
6amended in a manner that is consistent with this part.

7

SEC. 2.  

Section 117620 of the Health and Safety Code is
8repealed.

9

SEC. 3.  

Section 117630 of the Health and Safety Code is
10repealed.

11

SEC. 4.  

Section 117630 is added to the Health and Safety Code,
12to read:

13

117630.  

“Biohazard bag” means a disposable film bag that is
14impervious to moisture. The film bags that are used for transport
15shall be marked and certified by the manufacturer as having passed
16the tests prescribed for tear resistance in the American Society for
17Testing Materials (ASTM) D1922, “Standard Test Method for
18Propagation Tear Resistance of Plastic Film and Thin Sheeting by
19Pendulum Method” and for impact resistance in ASTM D 1709,
20“Standard Test Methods for Impact Resistance of Plastic Film by
21the Free-Falling Dart Method,” as those documents were published
22on January 1, 2014. The film bag shall meet an impact resistance
23of 165 grams and a tearing resistance of 480 grams in both parallel
24and perpendicular planes with respect to the length of the bag. The
25color of the bag shall be red, except when yellow bags are used to
26further segregate trace chemotherapy waste and white bags are
27used to further segregate pathology waste.

28

SEC. 5.  

Section 117635 of the Health and Safety Code is
29repealed.

30

SEC. 6.  

Section 117636 is added to the Health and Safety Code,
31to read:

32

117636.  

“Chemotherapeutic agent” means an agent that kills
33or prevents the reproduction of malignant cells. Chemotherapeutic
34agent excludes anti-inflammatory and antibiotic medications used
35to treat malignant cells in the practice of veterinary medicine.

36

SEC. 7.  

Section 117647 is added to the Health and Safety Code,
37to read:

38

117647.  

“Empty” means a condition achieved when tubing,
39a container, or inner liner removed from a container that previously
40contained liquid or solid material, including, but not limited to, a
P8    1chemotherapeutic agent, is considered empty. The tubing,
2container, or inner liner removed from the container shall be
3considered empty if it has been emptied so that the following
4conditions are met:

5(a) If the material that the tubing, container, or inner liner held
6is pourable, no material can be poured or drained from the tubing,
7container, or inner liner when held in any orientation, including,
8but not limited to, when tilted or inverted.

9(b) If the material that thebegin delete tubing, container,end deletebegin insert containerend insert or inner
10liner held is not pourable, no material or waste remains in the
11container or inner liner that can feasibly be removed by scraping.

12

SEC. 8.  

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

SEC. 9.  

Section 117690 of the Health and Safety Code is
19repealed.

20

SEC. 10.  

Section 117690 is added to the Health and Safety
21Code
, to read:

22

117690.  

(a) “Medical waste” means any biohazardous,
23pathology, pharmaceutical, or trace chemotherapy waste not
24regulated by the federal Resource Conservation and Recovery Act
25of 1976 (Public Law 94-580), as amended; sharps and trace
26chemotherapy wastes generated in a health care setting in the
27diagnosis, treatment, immunization, or care of humans or animals;
28waste generated in autopsy or necropsy; waste generated during
29preparation of a body for final disposition such as cremation or
30interment; waste generated in research pertaining to the production
31or testing of microbiologicals; waste generated in research using
32human or animal pathogens; sharps and laboratory waste that poses
33a potential risk of infection to humans generated in the inoculation
34of animals in commercial farming operations; waste generated
35from the consolidation of home-generated sharps; and waste
36generated in the cleanup of trauma scenes. Biohazardous,
37pathology, pharmaceutical, sharps, and trace chemotherapy wastes
38that meet the conditions of this section are not subject to any of
39the hazardous waste requirements found in Chapter 6.5
40(commencing with Section 25100) of Division 20.

P9    1(b) For purposes of this part the following definitions apply:

2(1) “Biohazardous waste” includes all of the following:

3(A) (i) Regulated medical waste, clinical waste, or biomedical
4waste that is a waste or reusable material derived from the medical
5treatment of a human or from an animal that is suspected by the
6attending veterinarian of being infected with a pathogen that is
7also infectious to humans, which includes diagnosis and
8immunization; or from biomedical research, which includes the
9production and testing of biological products.

10 (ii) Regulated medical waste or clinical waste or biomedical
11waste suspected of containing a highly communicable disease.

12(B) Laboratory waste such as human specimen cultures or
13animal specimen cultures that are infected with pathogens that are
14also infectious to humans; cultures and stocks of infectious agents
15from research; wastes from the production of bacteria, viruses,
16spores, discarded live and attenuated vaccines used in human health
17care or research, discarded animal vaccines, including Brucellosis
18and Contagious Ecthyma, as defined by the department; culture
19dishes, devices used to transfer, inoculate, and mix cultures; and
20wastes identified by Section 173.134 of Title 49 of the Code of
21Federal Regulations as Category B “once wasted” for laboratory
22wastes.

23(C) Waste that, at the point of transport from the generator’s
24site or at the point of disposal contains recognizable fluid human
25blood, fluid human blood products, containers, or equipment
26containing human blood that is fluid, or blood from animals
27suspected by the attending veterinarian of being contaminated with
28infectious agents known to be contagious to humans.

29(D) Waste containing discarded materials contaminated with
30excretion, exudate, or secretions from humans or animals that are
31required to be isolated by the infection control staff, the attending
32physician and surgeon, the attending veterinarian, or the local
33health officer, to protect others from highly communicable diseases
34or diseases of animals that are communicable to humans.

35(2) Pathology waste includes both of the following:

36(A) Human body parts, with the exception of teeth, removed at
37surgery and surgery specimens or tissues removed at surgery or
38autopsy that are suspected by the health care professional of being
39contaminated with infectious agents known to be contagious to
40humans or having been fixed in formaldehyde or another fixative.

P10   1(B) Animal parts, tissues, fluids, or carcasses suspected by the
2attending veterinarian of being contaminated with infectious agents
3known to be contagious to humans.

4(3) “Pharmaceutical waste” means a pharmaceutical, as defined
5in Section 117747, includingbegin delete fluid bulkend deletebegin insert traceend insert chemotherapy waste,
6that is a waste, as defined in Section 25124. For purposes of this
7part, “pharmaceutical waste” does not include a pharmaceutical
8that meets either of the following criteria:

9(A) The pharmaceutical is being sent out of the state to a reverse
10distributor, as defined in Section 4040.5 of the Business and
11Professions Code, that is licensed as a wholesaler of dangerous
12drugs by the California State Board of Pharmacy pursuant to
13Section 4161 of the Business and Professions Code.

14(B) The pharmaceutical is being sent by a reverse distributor,
15as defined in Section 4040.5 of the Business and Professions Code,
16offsite for treatment and disposal in accordance with applicable
17laws, or to a reverse distributor that is licensed as a wholesaler of
18dangerous drugs by the California State Board of Pharmacy
19pursuant to Section 4160 of the Business and Professions Code
20and as a permitted transfer station if the reverse distributor is
21located within the state.

22(4) “Sharps waste” means a device that has acute rigid corners,
23edges, or protuberances capable of cutting or piercing, including,
24but not limited to, hypodermic needles, hypodermic needles with
25syringes, blades, needles with attached tubing, acupuncture needles,
26root canal files, broken glass items used in health care such as
27Pasteur pipettes and blood vials contaminated with biohazardous
28waste, and any item capable of cutting or piercing from trauma
29scene waste.

30(5) “Trace chemotherapeutic waste” means waste that is
31contaminated through contact with, or having previously contained,
32chemotherapeutic agents, including, but not limited to, gloves,
33disposable gowns, towels, and intravenous solution bags and
34attached tubing that are empty. A biohazardous waste that meets
35the conditions of this paragraph is not subject to the hazardous
36waste requirements of Chapter 6.5 (commencing with Section
3725100) of Division 20.

38(6) “Trauma scene waste” means waste that is a regulated waste,
39as defined in Section 5193 of Title 8 of the California Code of
40Regulations, and that has been removed, is to be removed, or is in
P11   1the process of being removed, from a trauma scene by a trauma
2scene waste management practitioner.

3

SEC. 11.  

Section 117695 of the Health and Safety Code is
4amended to read:

5

117695.  

Medical waste that has been treated in accordance
6with the provisions of the Medical Waste Management Act,
7Chapter 8 (commencing with Section 118215), and that is not
8otherwise hazardous, shall thereafter be considered solid waste as
9defined in Section 40191 of the Public Resources Code and not
10medical waste.

11

SEC. 12.  

Section 117700 of the Health and Safety Code is
12amended to read:

13

117700.  

Medical waste does not include any of the following:

14(a) Waste generated in food processing or biotechnology that
15does not contain an infectious agent, as defined in Section 117675,
16or an agent capable of causing an infection that is highly
17communicable, as defined in Section 117665.

18(b) Waste generated in biotechnology that does not contain
19human blood or blood products or animal blood or blood products
20suspected of being contaminated with infectious agents known to
21be communicable to humans or a highly communicable disease.

22(c) Urine, feces, saliva, sputum, nasal secretions, sweat, tears,
23or vomitus, unless it contains visible or recognizable fluid blood,
24as provided in subparagraph (C) of paragraph (1) of subdivision
25(b) of Section 117690.

26(d) Waste which is not biohazardous, such as paper towels,
27paper products, articles containing nonfluid blood, and other
28medical solid waste products commonly found in the facilities of
29medical waste generators.

30(e) Hazardous waste, radioactive waste, or household waste,
31including, but not limited to, home-generated sharps waste, as
32defined in Section 117671.

33(f) Waste generated from normal and legal veterinarian,
34agricultural, and animal livestock management practices on a farm
35or ranch unless otherwise specified in law.

36

SEC. 13.  

Section 117710 of the Health and Safety Code is
37amended to read:

38

117710.  

“Medical waste management plan” means a document
39that is completed by generators of medical waste that describes
40how the medical waste generated at their facility shall be
P12   1segregated, handled, stored, packaged, treated, or shipped for
2treatment, as applicable, pursuant to Section 117935 for small
3quantity generators and Section 117960 for large quantity
4generators, on forms prepared by the enforcement agency, if those
5forms are provided by the enforcement agency.

6

SEC. 14.  

Section 117725 of the Health and Safety Code is
7amended to read:

8

117725.  

(a) “Medical waste treatment facility” means all land
9and structures, and other appurtenances or improvements on the
10land under the control of the treatment facility, used for treating
11medical waste offsite from a medical waste generator, including
12all associated handling and storage of medical waste as permitted
13by the department.

14(b) For purposes of this section, land is under the control of the
15treatment facility if it is owned, rented, or controlled by contractual
16agreement.

17

SEC. 15.  

Section 117747 of the Health and Safety Code is
18amended to read:

19

117747.  

(a) “Pharmaceutical” means a prescription or
20over-the-counter human or veterinary drug, including, but not
21limited to, a drug as defined in Section 109925 of the Federal Food,
22Drug, and Cosmetic Act, as amended, (21 U.S.C.A. Sec. 321(g)(1)).

23(b) For purposes of this part, “pharmaceutical” does not include
24any pharmaceutical that is regulated pursuant to either of the
25following:

26(1) The federal Resource Conservation and Recovery Act of
271976, as amended (42 U.S.C.A. Sec. 6901 et seq.). This waste
28stream shall be handled as a hazardous waste under the authority
29of Chapter 6.5 (commencing with Section 25100) of Division 20.

30(2) The Radiation Control Law (Chapter 8 (commencing with
31Section 114960) of Part 9).

32

SEC. 16.  

Section 117748 of the Health and Safety Code is
33repealed.

34

SEC. 17.  

Section 117750 of the Health and Safety Code is
35repealed.

36

SEC. 18.  

Section 117750 is added to the Health and Safety
37Code
, to read:

38

117750.  

(a) “Sharps container” means a rigid puncture-resistant
39container used in patient care or research activities meeting the
40standards of, and receiving approval from, the United States Food
P13   1and Drug Administration as a medical device used for the collection
2of discarded medical needles or other sharps.

3(b) Sharps containers, including those used to containerize trace
4chemotherapeutic wastes, shall not be lined with a plastic bag or
5inner liner.

6

SEC. 19.  

Section 117755 of the Health and Safety Code is
7repealed.

8

SEC. 20.  

Section 117765 of the Health and Safety Code is
9amended to read:

10

117765.  

“Storage” means the holding of medical wastes, in
11compliance with the Medical Waste Management Act, including
12Chapter 9 (commencing with Section 118275), at a designated
13accumulation area, offsite point of consolidation, transfer station,
14other registered facility, or in a vehicle detached from its means
15of locomotion.

begin delete16

SEC. 21.  

Section 117770 of the Health and Safety Code is
17repealed.

end delete
18

begin deleteSEC. 22.end delete
19begin insertSEC. 21.end insert  

Sectionbegin delete 117770end deletebegin insert 117771end insert is added to the Health and
20Safety Code
, to read:

21

begin delete117770.end delete
22begin insert117771.end insert  

“Shipping document” means the medical waste
23shipping document required by the United States Department of
24Transportation pursuant to Section 172.200 et seq. of Title 49 of
25the Code of Federal Regulations or the document required by the
26United States Postal Service pursuant to Domestic Mail Manual
27601.10.17.5 (Mailability: Hazardous Materials: Sharps and Other
28Mailable Regulated Medical Waste).

29

begin deleteSEC. 23.end delete
30begin insertSEC. 22.end insert  

Section 117775 of the Health and Safety Code is
31amended to read:

32

117775.  

(a) “Transfer station” means an offsite location
33permitted by the department where medical waste is loaded,
34unloaded, stored, or consolidated by a registered hazardous waste
35hauler during the normal course of transportation of the medical
36waste.

37(b) “Transfer station” does not include any onsite facility,
38including, but not limited to, common storage facilities, facilities
39of medical waste generators employed for the purpose of
40consolidation, or onsite treatment facilities.

P14   1

begin deleteSEC. 24.end delete
2begin insertSEC. 23.end insert  

Section 117777 of the Health and Safety Code is
3repealed.

4

begin deleteSEC. 25.end delete
5begin insertSEC. 24.end insert  

Section 117780 of the Health and Safety Code is
6amended to read:

7

117780.  

“Treatment” means any method, technique, or process
8designed to change or destroy the biological character or
9composition of any medical waste so as to eliminate its potential
10for causing disease or creating public or environmental harm, as
11specified in Chapter 8 (commencing with Section 118215).

12

begin deleteSEC. 26.end delete
13begin insertSEC. 25.end insert  

Section 117805 of the Health and Safety Code is
14amended to read:

15

117805.  

A local agency that elects to implement a medical
16waste management program shall notify the department of its intent
17to do so.

18

begin deleteSEC. 27.end delete
19begin insertSEC. 26.end insert  

Section 117820 of the Health and Safety Code is
20amended to read:

21

117820.  

A medical waste management program shall include,
22but not be limited to, all of the following:

23(a) Issuing medical waste registrations and permits pursuant to
24the Medical Waste Management Act.

25(b) Processing and reviewing the medical waste management
26plans and inspecting onsite treatment facilities in accordance with
27Chapter 4 (commencing with Section 117925) for all small quantity
28medical waste generators required to be registered.

29(c) Conducting an evaluation, inspection, or records review for
30all facilities or persons issued a large quantity medical waste
31registration pursuant to Chapter 5 (commencing with Section
32 117950) or issued a permit for an onsite medical waste treatment
33facility pursuant to Chapter 7 (commencing with Section 118130).

34(d) Inspecting medical waste generators in response to
35complaints or emergency incidents, or as part of an investigation
36or evaluation of the implementation of the medical waste
37management plan.

38(e) Inspecting medical waste treatment facilities in response to
39a complaint or as part of an investigation or emergency incident.

P15   1(f) Taking enforcement action for the suspension or revocation
2of medical waste permits issued by the local agency pursuant to
3this part.

4(g) Referring or initiating proceedings for civil or criminal
5prosecution of violations specified in Chapter 10 (commencing
6with Section 118335).

7(h) Reporting in a manner determined by the department so that
8the statewide effectiveness of the program can be determined.

9

begin deleteSEC. 28.end delete
10begin insertSEC. 27.end insert  

Section 117835 of the Health and Safety Code is
11amended to read:

12

117835.  

The department shall establish and maintain a database
13of persons registered as small quantity generators and as large
14quantity generators for whom the department is the enforcement
15agency under Chapter 4 (commencing with Section 117925) and
16Chapter 5 (commencing with Section 117950).

17

begin deleteSEC. 29.end delete
18begin insertSEC. 28.end insert  

Section 117885 of the Health and Safety Code is
19amended to read:

20

117885.  

(a) There is in the State Treasury the Medical Waste
21Management Fund, that shall be administered by the director.
22Money deposited in the fund shall be available to the department,
23upon appropriation by the Legislature, for the purposes of this part.

24(b) In addition to any other funds transferred by the Legislature
25to the Medical Waste Management Fund, the following shall be
26deposited in the fund:

27(1) Fees, penalties, interest earned, and fines collected by, or
28on behalf of, the department pursuant to this part.

29(2) Funds granted by the federal government for purposes of
30carrying out this part.

31

begin deleteSEC. 30.end delete
32begin insertSEC. 29.end insert  

Section 117890 of the Health and Safety Code is
33amended to read:

34

117890.  

(a) No large quantity generator shall generate medical
35waste unless the large quantity generator is registered with the
36enforcement agency pursuant to this part.

37(b) Registration pursuant to this part shall also allow the large
38quantity generator to generate medical waste at temporary events,
39including, but not limited to, health fairs, vaccination clinics, and
40veteran stand downs, without further registration or permitting
P16   1required. The large quantity generator shall notify the local
2enforcement agency of their intended participation in a temporary
3event at least 72 hours before the event, unless the sponsor of the
4temporary event previously notified the local enforcement agency
5of the event.

6

begin deleteSEC. 31.end delete
7begin insertSEC. 30.end insert  

Section 117895 of the Health and Safety Code is
8repealed.

9

begin deleteSEC. 32.end delete
10begin insertSEC. 31.end insert  

Section 117895 is added to the Health and Safety
11Code
, to read:

12

117895.  

Registration pursuant to this part shall allow a small
13quantity generator to generate medical waste at temporary events,
14including, but not limited to, health fairs, vaccination clinics, and
15veteran stand downs, without further registration or permitting
16required. The small quantity generator shall notify the local
17enforcement agency of their intended participation in a temporary
18event at least 72 hours before the event, unless the sponsor of the
19temporary event previously notified the local enforcement agency
20of the event.

21

begin deleteSEC. 33.end delete
22begin insertSEC. 32.end insert  

Section 117900 of the Health and Safety Code is
23amended to read:

24

117900.  

No person shall haul medical waste unless the person
25is one of the following:

26(a) A registered hazardous waste hauler pursuant to the
27requirements of Chapter 6.5 (commencing with Section 25100) of
28Division 20.

29(b) A mail-back system approved by the United States Postal
30Service.

31(c) A common carrier allowed to haul pharmaceutical waste
32pursuant to Section 118029 or 118032.

33(d) A small quantity generator or a large quantity generator
34transporting limited quantities of medical waste with an exemption
35granted pursuant to either Section 117946 or Section 117976,
36respectively.

37(e) A registered trauma scene waste practitioner hauling trauma
38scene waste pursuant to Section 118321.5.

P17   1

begin deleteSEC. 34.end delete
2begin insertSEC. 33.end insert  

Section 117903 of the Health and Safety Code is
3amended to read:

4

117903.  

No person shall treat medical waste unless the person
5is permitted by the enforcement agency as required by this part or
6unless the treatment is performed by a medical waste generator
7and is a treatment method approved pursuant to Chapter 8
8(commencing with Section 118215).

9

begin deleteSEC. 35.end delete
10begin insertSEC. 34.end insert  

Section 117904 of the Health and Safety Code is
11amended to read:

12

117904.  

(a) In addition to the consolidation points authorized
13pursuant to Section 118147, the enforcement agency may approve
14a location as a point of consolidation for the collection of
15home-generated sharps waste, which, after collection, shall be
16transported and treated as medical waste.

17(b) A consolidation location approved pursuant to this section
18shall be known as a “home-generated sharps consolidation point.”

19(c) A home-generated sharps consolidation point is not subject
20to the requirements of Chapter 9 (commencing with Section
21118275), to the permit or registration requirements of this part, or
22to any permit or registration fees, with regard to the activity of
23 consolidating home-generated sharps waste pursuant to this section.

24(d) A home-generated sharps consolidation point shall comply
25with all of the following requirements:

26(1) All sharps waste shall be placed in sharps containers.

27(2) Sharps containers ready for disposal shall not be held for
28more than seven days without the written approval of the
29enforcement agency.

30(e) An operator of a home-generated sharps consolidation point
31approved pursuant to this section shall not be considered the
32generator of that waste, but shall be listed on the shipping document
33in compliance with United States Department of Transportation
34and United States Postal Service requirements.

35(f) The medical waste treatment facility which treats the sharps
36waste subject to this section shall maintain the shippingbegin insert and
37trackingend insert
documents required bybegin delete Sectionend deletebegin insert Sections 118040 andend insert
38 118165 with regard to that sharps waste.

P18   1

begin deleteSEC. 36.end delete
2begin insertSEC. 35.end insert  

Section 117918 of the Health and Safety Code is
3amended to read:

4

117918.  

Medical waste shall be treated using treatment
5technologiesbegin delete approvedend delete in accordance with Chapter 8 (commencing
6with Section 118215).

7

begin deleteSEC. 37.end delete
8begin insertSEC. 36.end insert  

Section 117920 of the Health and Safety Code is
9amended to read:

10

117920.  

The fee schedule specified in Section 117923 shall be
11for the issuance of medical waste registrations and for conducting
12inspections pursuant to this chapter when the department serves
13as the enforcement agency for small quantity generators. This fee
14schedule shall be adjusted annually in accordance with Section
15100425, or as provided in the regulations adopted by the
16department, not to exceed the reasonable regulatory costs of the
17department. Local enforcement agencies shall set fees that shall
18be sufficient to cover their costs in implementing this part with
19regard to small quantity generators required to be registered
20pursuant to Section 117925.

21

begin deleteSEC. 38.end delete
22begin insertSEC. 37.end insert  

Section 117924 of the Health and Safety Code is
23amended to read:

24

117924.  

(a) When the department is the enforcement agency,
25the department shall impose and cause the collection of an annual
26medical waste generator fee in an amount not to exceed twenty-five
27dollars ($25) on small quantity generators of medical waste, except
28for those small quantity generators that are required to register
29pursuant to Section 117925 and those generators generating only
30pharmaceutical waste as defined in paragraph (3) of subdivision
31(b) of Section 117690. Nothing in this part shall prevent the
32department from contracting with entities other than the department
33for these fee collection activities or from entering into agreements
34with medical waste transporters for the collection of these fees, if
35the department determines that such a fee collection arrangement
36would be cost effective.

37(b) If the department determines to enter into a contract with a
38medical waste transporter for the collection of the fees, the
39department shall do all of the following:

P19   1(1) Establish that not more than 7.5 percent of the fees collected
2may be recovered by the medical waste transporter as
3administrative costs for the collection of those fees.

4(2) Establish that the administrative costs for the collection of
5the fees shall be the same for all medical waste transporters.

6(3) Prohibit any medical waste transporter from waiving the
7generator fee without the written approval of the department and
8only if the medical waste generator has made a written request for
9the waiver.

10(4) Require the medical waste transporter to report the fees
11collected pursuant to subdivision (a) to the department.

12(5) Prohibit the medical waste transporter from assuming the
13role of the department as an enforcement agent for purposes of
14collecting the medical waste generator fees.

15(6) Require medical waste transporters to include the following
16language in at least 12-point type on their invoices to medical
17waste generators:

18“Pursuant to Section 117924 of the California Health and Safety
19Code, the State Department of Public Health has contracted with
20us to collect your annual medical waste generator fee. The
21department may offset our costs of collection and administration
22in an amount that may not exceed 7.5 percent of the fee collected.
23We may not waive the fee without written approval of the
24department, and only if you have made a written request for the
25waiver.”

26(7) Ensure that generators subject to this section are required
27to pay the fee only once per year.

28

begin deleteSEC. 39.end delete
29begin insertSEC. 38.end insert  

Section 117928 of the Health and Safety Code is
30amended to read:

31

117928.  

(a)  Any common storage facility for the collection
32of medical waste produced by small quantity generators operating
33independently, but sharing common storage facilities, shall have
34a permit issued by the enforcement agency prior to the
35commencement of storage of medical waste in the common storage
36facility.

37(b)  A permit for any common storage facility specified in
38subdivision (a) may be obtained by any one of the following:

39(1)  A provider of health care as defined in Section 56.05 of the
40Civil Code.

P20   1(2)  The registered hazardous waste transporter.

2(3)  The property owner.

3(4)  The property management firm responsible for providing
4tenant services to the medical waste generators.

5

begin deleteSEC. 40.end delete
6begin insertSEC. 39.end insert  

Section 117933 of the Health and Safety Code is
7repealed.

8

begin deleteSEC. 41.end delete
9begin insertSEC. 40.end insert  

Section 117935 of the Health and Safety Code is
10amended to read:

11

117935.  

A small quantity generator required to register with
12the enforcement agency pursuant to Section 117930 shall file with
13the enforcement agency a medical waste management plan on
14forms prescribed by the enforcement agency, if provided. The
15plans shall contain, but are not limited to, all of the following:

16(a) The name of the person.

17(b) The business address of the person.

18(c) The type of business.

19(d) The types, and the estimated average monthly quantity, of
20medical waste generated.

21(e) The type of treatment used onsite.

22(f) The name and business address of the registered hazardous
23waste hauler used by the generator for backup treatment and
24disposal, for waste when the onsite treatment method is not
25appropriate due to the hazardous or radioactive characteristics of
26the waste.

27(g) The name of the registered hazardous waste hauler used by
28the generator to have untreated medical waste removed for
29treatment and disposal, if applicable.

30(h) The name of the common carrier used by the generator to
31transport pharmaceutical waste offsite for treatment and disposal
32pursuant to Section 118032, if applicable.

33(i) If applicable, the steps taken to categorize the pharmaceutical
34wastes generated at the facility to ensure that the wastes are
35properly disposed of as follows:

36(1) Pharmaceutical wastes classified by the federal Drug
37 Enforcement Agency (DEA) as “controlled substances” are
38disposed of in compliance with DEA requirements.

39(2) The name and business address of the registered hazardous
40waste hauler used by the generator to have wastes that are not
P21   1regulated pursuant to the federal Resource Conservation and
2Recovery Act of 1976 and nonradioactive pharmaceutical wastes
3regulated as medical waste safely removed for treatment in
4compliance with subdivision (b) of Section 118222 as waste
5requiring specific methods.

6(j) A closure plan for the termination of treatment at the facility
7using, at a minimum, one of the methods of decontamination
8specified in subdivision (a) or (b) of Section 118295, thereby
9rendering the property to an acceptable sanitary condition following
10the completion of treatment services at the site.

11(k) A statement certifying that the information provided is
12complete and accurate.

13

begin deleteSEC. 42.end delete
14begin insertSEC. 41.end insert  

Section 117938 of the Health and Safety Code is
15amended to read:

16

117938.  

(a) Small quantity generators using onsite steam
17sterilization, incineration, or microwave technology to treat medical
18waste are subject to biennial inspection of that onsite treatment
19facility by the enforcement agency and may be subject to the
20permitting requirements for onsite medical waste treatment
21facilities as determined by the enforcement agency.

22(b) (1) The operators of the treatment equipment specified in
23subdivision (a) shall be required to receive training in the operation
24of the treatment equipment, proper protective equipment to wear,
25if any, how to clean up spills, and other information required to
26operate the treatment equipment in a safe and effective manner.

27(2) Annual training for the operators shall be provided after the
28initial training has been completed.

29(3) The training shall be documented for each treatment operator
30and retained on file at the generator facility for a minimum of two
31years. Training shall comply with applicable federal Occupational
32Safety and Health Administration regulations, including those
33found in Section 1910 of Title 29 of the Code of Federal
34Regulations.

35

begin deleteSEC. 43.end delete
36begin insertSEC. 42.end insert  

Section 117940 of the Health and Safety Code is
37amended to read:

38

117940.  

(a) Each enforcement agency shall follow procedures
39consistent with this chapter in registering medical waste generators.

P22   1(b) Each medical waste generator registration for small quantity
2generators issued by the enforcement agency shall be valid for two
3years.

4(c) An application for renewal of the registration for small
5quantity generators shall be filed with the enforcement agency on
6or before the expiration date.

7(d) Generators shall submit an updated application form when
8any of the information specified in their medical waste management
9plan, created pursuant to Section 117935, changes. The updated
10application form shall be submitted within 30 days of the change.

11

begin deleteSEC. 44.end delete
12begin insertSEC. 43.end insert  

Section 117943 of the Health and Safety Code is
13amended to read:

14

117943.  

(a) A medical waste generator required to register
15pursuant to this chapter shall maintain for a minimum of three
16years individual treatment operating records, and if applicable,
17shippingbegin insert and trackingend insert documents for all untreated medical waste
18shipped offsite for treatment, and shall report or submit to the
19enforcement agency, upon request, all of the following:

20(1) Treatment operating records. Operating records shall be
21maintained in written or electronic form.

22(2) An emergency action plan complying with regulations
23adopted by the department.

24(3) Shippingbegin insert and trackingend insert documents or electronically archived
25shippingbegin insert and trackingend insert documents maintained by the facility and
26medical waste hauler of all untreated medical waste shipped offsite
27for treatment.

28(b) Documentation shall be made available to the enforcement
29agency onsite.

30

begin deleteSEC. 45.end delete
31begin insertSEC. 44.end insert  

Section 117945 of the Health and Safety Code is
32amended to read:

33

117945.  

(a) Small quantity generators who are not required
34to register pursuant to this chapter shall maintain on file in their
35office all of following:

36(1) An information document stating how the generator contains,
37stores, treats, and disposes of any medical waste generated through
38any act or process of the generator.

39(2) Records required by the United States Department of
40Transportation or the United States Postal Service of any medical
P23   1waste shipped offsite for treatment and disposal. The small quantity
2generator shall maintain, or have available electronically at the
3facility or from the medical waste hauler or common carrier, these
4records, for not less than three years.

5(b) Documentation shall be made available to the enforcement
6agency onsite.

7

begin deleteSEC. 46.end delete
8begin insertSEC. 45.end insert  

Section 117946 is added to the Health and Safety
9Code
, to read:

10

117946.  

(a) A small quantity medical waste generator or parent
11organization that employs health care professionals who generate
12medical waste may transport medical waste generated in limited
13quantities up tobegin delete 37.5end deletebegin insert 35.2end insert pounds to the central location of
14accumulation, provided that all of the following are met:

15(1) The principal business of the generator is not to transport
16or treat regulated medical waste.

17(2) The generator shall adhere to the conditions and requirements
18set forth in the materials of trade exception, as specified in Section
19173.6 of Title 49 of the Code of Federal Regulations.

20(3) A person transporting medical waste pursuant to this section
21shall provide a form or log to the receiving facility, and the
22receiving facility shall maintain the form or log for a period of two
23years, containing all of the following information:

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

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

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

27(b) A generator transporting medical waste pursuant to this
28section shall not be regulated as a hazardous waste hauler pursuant
29to Section 117660.

30

begin deleteSEC. 47.end delete
31begin insertSEC. 46.end insert  

Section 117950 of the Health and Safety Code is
32amended to read:

33

117950.  

(a) Each large quantity generator, except as specified
34in subdivisions (b) and (c), shall register with the enforcement
35agency prior to commencement of the generation of medical waste.

36(b) Large quantity generators operating as a business in the same
37building, or that are associated with a group practice in the same
38building, may register as one generator.

39(c) Large quantity generators as specified in subdivision (a),
40operating in different buildings on the same or adjacent property,
P24   1or as approved by the enforcement agency, may register as one
2generator.

3(d) “Adjacent,” for purposes of subdivision (c), means real
4property within 400 yards from the property boundary of the
5primary registration site. All federal transportation requirements
6specified in Section 173.6 of Part 49 of the Code of Federal
7Regulations shall apply for purposes of transporting medical waste
8from adjacent properties.

9

begin deleteSEC. 48.end delete
10begin insertSEC. 47.end insert  

Section 117955 of the Health and Safety Code is
11repealed.

12

begin deleteSEC. 49.end delete
13begin insertSEC. 48.end insert  

Section 117960 of the Health and Safety Code is
14amended to read:

15

117960.  

A large quantity generator required to register with
16the enforcement agency shall file with the enforcement agency a
17medical waste management plan, on forms prescribed by the
18enforcement agency, if provided. The plans shall contain, but are
19not limited to, all of the following:

20(a) The name of the person.

21(b) The business address of the person.

22(c) The type of business.

23(d) The types, and the estimated average monthly quantity, of
24medical waste generated.

25(e) The type of treatment used onsite, if applicable. For
26generators with onsite medical waste treatment facilities, the
27treatment capacity of the onsite treatment facility.

28(f) The name and business address of the registered hazardous
29waste hauler used by the generator to have untreated medical waste
30removed for treatment, if applicable, and, if applicable, the name
31and business address of the common carrier transporting
32pharmaceutical waste pursuant to Section 118032.

33(g) The name and business address of the offsite medical waste
34treatment facility to which the medical waste is being hauled, if
35applicable.

36(h) An emergency action plan complying with regulations
37adopted by the department.

38(i) If applicable, the steps taken to categorize the pharmaceutical
39wastes generated at the facility to ensure that the wastes are
40properly disposed of as follows:

P25   1(1) Pharmaceutical wastes classified by the federal Drug
2Enforcement Agency (DEA) as “controlled substances” are
3 disposed of in compliance with DEA requirements.

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

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

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

17

begin deleteSEC. 50.end delete
18begin insertSEC. 49.end insert  

Section 117967 is added to the Health and Safety
19Code
, to read:

20

117967.  

(a) Large quantity generators that treat medical waste
21onsite using steam sterilization, incineration, microwave
22technology, or other department approved treatment technology
23to treat medical waste shall train the operators of the equipment
24in its use, proper protective equipment to wear, if necessary, and
25how to clean up spills to ensure that the equipment is being
26operated in a safe and effective manner.

27(b) Annual training for the operators shall be provided after the
28initial training has been completed.

29(c) The training shall be documented and the documentation
30shall be retained at the facility for a minimum of two years.
31 Training shall comply with applicable federal Occupational Safety
32and Health Administration regulations, including those found in
33Section 1910 of Title 29 of the Code of Federal Regulations.

34

begin deleteSEC. 51.end delete
35begin insertSEC. 50.end insert  

Section 117970 of the Health and Safety Code is
36amended to read:

37

117970.  

(a) Each enforcement agency shall follow procedures
38consistent with this chapter in registering medical waste generators.

39(b) Each medical waste registration issued by the enforcement
40agency for large quantity generators shall be valid for one year.

P26   1(c) An application for renewal of the registration shall be filed
2with the enforcement agency not less than 90 days prior to the
3expiration date. Failure to meet this requirement shall result in an
4assessment of a late fee.

5(d) Generators shall update their medical waste management
6plan, established pursuant to Section 117960, when any of the
7information in the plan changes and shall have the plan on file for
8review during an inspection or upon request. The updated plan
9shall be submitted within 30 days of the change.

10

begin deleteSEC. 52.end delete
11begin insertSEC. 51.end insert  

Section 117975 of the Health and Safety Code is
12repealed.

13

begin deleteSEC. 53.end delete
14begin insertSEC. 52.end insert  

Section 117975 is added to the Health and Safety
15Code
, to read:

16

117975.  

(a) A large quantity medical waste generator required
17to register pursuant to this chapter shall maintain for a minimum
18of two years individual treatment records and shippingbegin insert and trackingend insert
19 documents for all untreated medical waste shipped offsite for
20treatment. The generator shall report or submit to the enforcement
21agency, upon request, all of the following:

22(1) Treatment operating records. Operating records shall be
23maintained in written or electronic form.

24(2) An emergency action plan in accordance with regulations
25adopted by the department.

26(3) Shippingbegin insert and trackingend insert documents or electronically archived
27shippingbegin insert and trackingend insert documents maintained by the facility or
28medical waste hauler of all untreated medical wastes shipped offsite
29for treatment.

30(b) Documentation shall be made available to the enforcement
31agency onsite as soon as feasible, but no more than two business
32days following the request.

33

begin deleteSEC. 54.end delete
34begin insertSEC. 53.end insert  

Section 117976 is added to the Health and Safety
35Code
, to read:

36

117976.  

(a) A large quantity medical waste generator or parent
37organization that employs health care professionals who generate
38medical waste may transport medical waste generated in limited
39quantities up tobegin delete 37.5end deletebegin insert 35.2end insert pounds to the central location of
40accumulation, provided that all of the following are met:

P27   1(1) The principal business of the generator is not to transport
2or treat regulated medical waste.

3(2) The generator shall adhere to the conditions and requirements
4set forth in the materials of trade exception, as specified in Section
5173.6 of Title 49 of the Code of Federal Regulations.

6(3) A person transporting medical waste pursuant to this section
7shall provide a form or log to the receiving facility, and the
8receiving facility shall maintain the form or log for a period of two
9years, containing all of the following information:

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

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

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

13(b) A generator transporting medical waste pursuant to this
14section shall not be regulated as a hazardous waste hauler pursuant
15to Section 117660.

16

begin deleteSEC. 55.end delete
17begin insertSEC. 54.end insert  

Section 117985 of the Health and Safety Code is
18amended to read:

19

117985.  

Medical waste shall be treated using treatment
20technologies approved in accordance with Chapter 8 (commencing
21with Section 118215).

22

begin deleteSEC. 56.end delete
23begin insertSEC. 55.end insert  

Section 117990 of the Health and Safety Code is
24amended to read:

25

117990.  

The fee schedule specified in Section 117995 shall be
26for the issuance of medical waste registrations and onsite medical
27waste treatment facility permits when the department serves as the
28enforcement agency for large quantity generators. This fee schedule
29shall be adjusted annually in accordance with Section 100425, or
30as provided in the regulations adopted by the department, not to
31exceed the reasonable regulatory costs of the department. Local
32enforcement agencies shall set fees that shall be sufficient to cover
33their costs in implementing this part with regard to large quantity
34generators.

35

begin deleteSEC. 57.end delete
36begin insertSEC. 56.end insert  

Section 118000 of the Health and Safety Code is
37amended to read:

38

118000.  

(a) Medical waste shall only be transported to a
39permitted medical waste treatment facility, or to a transfer station
P28   1or another registered generator for the purpose of consolidation
2before treatment and disposal.

3(b) Facilities for the transfer of medical waste shall be annually
4inspected and issued permits in accordance with the regulations
5adopted pursuant to this part.

6(c) Medical waste transported out of state shall be consigned to
7a permitted medical waste treatment facility in the receiving state.
8If there is no permitted medical waste treatment facility in the
9receiving state or if the medical waste is crossing an international
10border, the medical waste shall be treated in accordance with
11 Chapter 8 (commencing with Section 118215) prior to being
12transported out of the state.

13

begin deleteSEC. 58.end delete
14begin insertSEC. 57.end insert  

Section 118005 of the Health and Safety Code is
15repealed.

16

begin deleteSEC. 59.end delete
17begin insertSEC. 58.end insert  

Section 118025 of the Health and Safety Code is
18amended to read:

19

118025.  

All medical waste shall be hauled by a registered
20hazardous waste hauler, the United States Postal Service, or by a
21person with an exception granted pursuant to Section 117946 for
22small quantity generators or pursuant to Section 117976 for large
23quantity generators.

24

begin deleteSEC. 60.end delete
25begin insertSEC. 59.end insert  

Section 118027 of the Health and Safety Code is
26amended to read:

27

118027.  

A person who is authorized to collect solid waste, as
28defined in Section 40191 of the Public Resources Code, who
29unknowingly transports medical waste to a solid waste facility, as
30defined in Section 40194 of the Public Resources Code, incidental
31to the collection of solid waste, is exempt from the provisions of
32the Medical Waste Management Act with regard to that waste. If
33a solid waste transporter discovers that he or she has hauled
34untreated medical waste to a landfill or materials recovery facility,
35he or she shall contact the originating generator of the medical
36waste to respond to the landfill or recovery facility to provide
37ultimate proper disposal of the medical waste. The solid waste
38facility operator may, at its discretion and after contacting the
39generator, make arrangements for the proper treatment and disposal
40of the medical waste at a facility approved by the department. Title
P29   1to the waste remains with the generator. Reimbursement costs for
2the proper management of discovered waste shall be the originating
3generator’s responsibility.

4

begin deleteSEC. 61.end delete
5begin insertSEC. 60.end insert  

Section 118029 of the Health and Safety Code is
6amended to read:

7

118029.  

(a) Haulers of medical waste in California, with the
8exception of those using a materials of trade exception as specified
9in Sections 117946 and 117976, and United States Department of
10Transportation licensed common carriers hauling pharmaceutical
11waste, shall meet all United States Department of Transportation
12requirements for transporting medical waste and shall be hazardous
13waste haulers in California. On or before July 1 of each year, a
14registered hazardous waste hauler that transports medical waste
15shall so notify the department, and provide, in a format that
16conforms to the protocol requirements for submission of data to
17the department, the following information:

18(1) Business name, address, and telephone number.

19(2) Name of owner, operator, and contact person.

20(3) Hazardous waste transporter registration number.

21(4) The number of vehicles and trailers transporting medical
22waste within the state as of that date.

23(5) Types and quantities of medical waste collected, in pounds.

24(6) The names of the generators whose waste has been
25transported by the hauler and the amounts of medical waste
26transported, by waste type category.

27(b)  Each registered hazardous waste hauler shall provide to the
28department a list of all medical waste generators serviced by that
29person during the previous 12 months. That list shall include the
30business name, business address, mailing address, telephone
31number, and other information as required by the department to
32collect annual fees pursuant to Section 117924. The list shall be
33provided to the department within 10 days of the close of the
34earliest calendar quarter ending September 30, December 31,
35March 31, or June 30, or as otherwise required by the department.

36

begin deleteSEC. 62.end delete
37begin insertSEC. 61.end insert  

Section 118030 of the Health and Safety Code is
38repealed.

P30   1

begin deleteSEC. 63.end delete
2begin insertSEC. 62.end insert  

Section 118032 of the Health and Safety Code is
3amended to read:

4

118032.  

A pharmaceutical waste generator or parent
5organization that employs health care professionals who generate
6pharmaceutical waste is exempt from the requirements of
7subdivision (a) of Section 118000 if all of the following
8requirements are met:

9(a) The generator or parent organization has on file one of the
10following:

11(1) If the generator or parent organization is a small quantity
12generator required to register pursuant to Chapter 4 (commencing
13with Section 117925), a medical waste management plan prepared
14pursuant to Section 117935.

15(2) If the generator or parent organization is a small quantity
16generator not required to register pursuant to Chapter 4
17 (commencing with Section 117925), the information document
18maintained pursuant to subdivision (a) of Section 117945.

19(3) If the generator or parent organization is a large quantity
20generator, a medical waste management plan prepared pursuant
21to Section 117960.

22(b) The generator or health care professional who generated the
23pharmaceutical waste transports the pharmaceutical waste himself
24or herself, or directs a member of his or her staff to transport the
25pharmaceutical waste to a parent organization or another health
26care facility for the purpose of consolidation before treatment and
27disposal, or contracts with a common carrier to transport the
28pharmaceutical waste to a permitted medical waste treatment
29facility or transfer station.

30(c) Except as provided in subdivision (d), all of the following
31requirements are met:

32(1) Prior to shipment of the pharmaceutical waste, the generator
33notifies the intended destination facility that it is shipping
34pharmaceutical waste to it and provides a copy of the shipping
35begin delete document,end deletebegin insert and tracking documents,end insert as specified in Sectionbegin delete 117770.end delete
36begin insert 118040.end insert

37(2) The generator and the facility receiving the pharmaceutical
38waste maintain thebegin delete shipping document,end deletebegin insert shipping and tracking
39documents,end insert
as specified in Sectionbegin delete 117770.end deletebegin insert 118040.end insert

P31   1(3) The facility receiving the pharmaceutical waste notifies the
2generator of the receipt of the pharmaceutical waste shipment and
3any discrepancies between the items received and thebegin delete shipping
4document,end delete
begin insert shipping and tracking documents,end insert as specified in Section
5begin delete 117770,end deletebegin insert 118040,end insert evidencing diversion of the pharmaceutical waste.

6(4) The generator notifies the enforcement agency of any
7discrepancies between the items received and thebegin delete shipping
8document,end delete
begin insert shipping and tracking documents,end insert as specified in Section
9begin delete 117770,end deletebegin insert 118040,end insert evidencing diversion of the pharmaceutical waste.

10(d) (1) Notwithstanding subdivision (c), if a health care
11professional who generates pharmaceutical waste returns the
12pharmaceutical waste to the parent organization for the purpose
13of consolidation before treatment and disposal over a period of
14time, a single-page form or multiple entry log may be substituted
15for the tracking document, if the form or log contains all of the
16following information:

17(A) The name of the person transporting the pharmaceutical
18waste.

19(B) The number of containers of pharmaceutical waste. This
20clause does not require any generator to maintain a separate
21pharmaceutical waste container for every patient or to maintain
22records as to the specified source of the pharmaceutical waste in
23any container.

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

25(2) The form or log described in paragraph (1) shall be
26maintained in the files of the health care professional who generates
27the pharmaceutical waste and the parent organization or another
28health care facility that receives the pharmaceutical waste.

29(3) This subdivision does not prohibit the use of a single
30document to verify the return of more than one container to a parent
31organization or another health care facility, provided the form or
32log meets the requirements specified in paragraphs (1) and (2).

33begin insert

begin insertSEC. 63.end insert  

end insert

begin insertSection 118040 of the end insertbegin insertHealth and Safety Codeend insertbegin insert is
34amended to read:end insert

35

118040.  

(a)  Except with regard to sharps waste consolidated
36by a home-generated sharps consolidation point approved pursuant
37to Section 117904, a hazardous waste transporter or generator
38transporting medical waste shall maintain a completedbegin delete trackingend delete
39begin insert shippingend insert documentbegin delete of all medical waste removed for treatment or
40disposal. Aend delete
begin insert in compliance with United States Department of
P32   1Transportation (USDOT) requirements when medical waste is
2transported. In addition to the shipping document required by
3USDOT, aend insert
hazardous waste transporter or generator who transports
4medical waste to a facility, other than the final medical waste
5treatment facility, shall also maintain tracking documents which
6show the name, address, and telephone number of the medical
7waste generator, for purposes of tracking the generator of medical
8waste when the waste is transported to the final medical waste
9treatment facility. At the time that the medical waste is received
10by a hazardous waste transporter, the transporter shall provide the
11medical waste generator with a copy of thebegin insert shipping andend insert tracking
12begin delete documentend deletebegin insert documentsend insert for the generator’s medical waste records.
13The transporter or generator transporting medical waste shall
14maintain its copy of thebegin insert shipping andend insert trackingbegin delete documentend deletebegin insert documentsend insert
15 for three years.

16(b)  The tracking document shall include, but not be limited to,
17all of the following information:

18(1)  The name, address, telephone number, and registration
19number of the transporter, unless transported pursuant to Section
20118030.

21(2)  The type of medical waste transported and the quantity or
22aggregate weight of medical waste transported.

23(3)  The name, address, and telephone number of the generator.

24(4)  The name, address, telephone number, permit number, and
25the signature of an authorized representative of the permitted
26facility receiving the medical waste.

27(5)  The date that the medical waste is collected or removed
28from the generator’s facility, the date that the medical waste is
29received by the transfer station, the registered large quantity
30generator, or point of consolidation, if applicable, and the date that
31the medical waste is received by the treatment facility.

32(c)  Any hazardous waste transporter or generator transporting
33medical waste in a vehicle shall havebegin delete aend deletebegin insert the shipping andend insert tracking
34begin delete documentend deletebegin insert documentsend insert in his or her possession while transporting
35the medical waste. The tracking document shall be shown upon
36demand to any enforcement agency personnel or officer of the
37Department of the California Highway Patrol. If the medical waste
38is transported by rail, vessel, or air, the railroad corporation, vessel
39operator, or airline shall enter on the shipping papers any
P33   1information concerning the medical waste that the enforcement
2agency may require.

3(d)  A hazardous waste transporter or a generator transporting
4medical waste shall provide the facility receiving the medical waste
5with the originalbegin insert shipping andend insert trackingbegin delete document.end deletebegin insert documents.end insert

6(e)  Each hazardous waste transporter and each medical waste
7treatment facility shall provide tracking data periodically and in a
8format as determined by the department.

begin delete

9(f)  Medical waste transported out of state shall be consigned
10to a permitted medical waste treatment facility in the receiving
11state. If there is no permitted medical waste treatment facility in
12the receiving state or if the medical waste is crossing an
13international border, the medical waste shall be treated in
14accordance with Chapter 8 (commencing with Section 118215)
15prior to being transported out of the state.

end delete
begin delete16

SEC. 64.  

Section 118040 of the Health and Safety Code is
17repealed.

end delete
18

begin deleteSEC. 65.end delete
19begin insertSEC. 64.end insert  

Section 118045 of the Health and Safety Code is
20amended to read:

21

118045.  

(a) The department shall charge an application fee
22for a permit for a transfer station equal to one hundred dollars
23($100) for each hour which the department spends on processing
24the application, but not more than ten thousand dollars ($10,000),
25or as provided in the regulations adopted by the department, not
26to exceed the reasonable regulatory costs of the department.

27(b) In addition to the fee specified in subdivision (a), the annual
28permit fee for a transfer station is two thousand dollars ($2,000),
29or as provided in the regulations adopted by the department, not
30to exceed the reasonable regulatory costs of the department.

31

begin deleteSEC. 66.end delete
32begin insertSEC. 65.end insert  

Section 118135 of the Health and Safety Code is
33amended to read:

34

118135.  

Each person operating an offsite medical waste
35treatment facility shall obtain a permit pursuant to this chapter
36from the department prior to commencement of the treatment
37facility’s operation.

38

begin deleteSEC. 67.end delete
39begin insertSEC. 66.end insert  

Section 118150 of the Health and Safety Code is
40amended to read:

P34   1

118150.  

Each enforcement agency shall follow procedures that
2are consistent with the Medical Waste Management Act and the
3regulations adopted pursuant to this chapter, when issuing medical
4waste permits.

5

begin deleteSEC. 68.end delete
6begin insertSEC. 67.end insert  

Section 118155 of the Health and Safety Code is
7amended to read:

8

118155.  

A person required to obtain an offsite medical waste
9treatment facility permit pursuant to this part shall file with the
10enforcement agency an application containing, but not limited to,
11all of the following:

12(a) The name of the applicant.

13(b) The business address of the applicant.

14(c) The type of treatment provided, the treatment capacity of
15the facility, a characterization of the waste treated at this facility
16and the estimated average monthly quantity of waste treated at the
17facility.

18(d) A disclosure statement, as provided in Section 25112.5,
19except for onsite medical waste treatment facilities.

20(e) A plan for closure of the facility using, at minimum, one of
21the methods of decontamination specified in subdivision (a) or (b)
22of Section 118295, thereby rendering the property to an acceptable
23sanitary condition following the ending of treatment services at
24the site.

25(f) Any other information required by the enforcement agency
26for the administration or enforcement of this part or the regulations
27adopted pursuant to this part.

28

begin deleteSEC. 69.end delete
29begin insertSEC. 68.end insert  

Section 118160 of the Health and Safety Code is
30amended to read:

31

118160.  

(a) Prior to issuing or renewing a permit for an offsite
32medical waste treatment facility, the department shall review the
33compliance history of the applicant, under any local, state, or
34federal law or regulation governing the control of medical waste
35or pollution.

36(b) The department shall, pursuant to this section, deny a permit,
37or specify additional permit conditions, to ensure compliance with
38applicable regulations, if the department determines that in the
39three-year period preceding the date of application the applicant
40has violated laws or regulations identified in subdivision (a) at a
P35   1facility owned or operated by the applicant, and the violations
2demonstrate a recurring pattern of noncompliance or pose, or have
3 posed, a significant risk to public health and safety or to the
4environment.

5(c) In making the determination of whether to deny a permit or
6to specify additional permit conditions, the department shall take
7both of the following into consideration:

8(1) Whether a permit denial or permit condition is appropriate
9or necessary given the severity of the violation.

10(2) Whether the violation has been corrected in a timely fashion.

11

begin deleteSEC. 70.end delete
12begin insertSEC. 69.end insert  

Section 118205 of the Health and Safety Code is
13amended to read:

14

118205.  

The fee schedule specified in Section 118210 shall
15cover the issuance of medical waste treatment facility permits and
16an inspection program, when the department serves as the
17enforcement agency. This fee schedule shall be adjusted annually
18in accordance with Section 100425. The department may adjust
19by regulation the fees specified in Section 118210 to reflect the
20actual costs of implementing this chapter. Local enforcement
21agencies shall set fees that shall be sufficient to cover their costs
22in implementing this part with regard to large quantity generators.

23

begin deleteSEC. 71.end delete
24begin insertSEC. 70.end insert  

Section 118215 of the Health and Safety Code is
25amended to read:

26

118215.  

(a) Except as provided in subdivisions (b) and (c), a
27person generating or treating medical waste shall ensure that the
28medical waste is treated by one of the following methods, thereby
29rendering it solid waste, as defined in Section 40191 of the Public
30Resources Code, prior to disposal:

31(1) (A) Incineration at a permitted medical waste treatment
32facility in a controlled-air, multichamber incinerator, or other
33method of incineration approved by the department which provides
34complete combustion of the waste into carbonized or mineralized
35ash.

36(B) Treatment with an alternative technology approved pursuant
37to paragraph (3), which, due to the extremely high temperatures
38of treatment in excess of 1300 degrees Fahrenheit, has received
39express approval from the department.

P36   1(2) Steam sterilization at a permitted medical waste treatment
2facility or by other sterilization, in accordance with all of the
3following operating procedures for steam sterilizers or other
4sterilization:

5(A) Standard written operating procedures shall be established
6for biological indicators, or for other indicators of adequate
7sterilization approved by the department, for each steam sterilizer,
8including time, temperature, pressure, type of waste, type of
9container, closure on container, pattern of loading, water content,
10and maximum load quantity.

11(B) Recording or indicating thermometers shall be checked
12during each complete cycle to ensure the attainment of 121°
13Centigrade (250° Fahrenheit) for at least one-half hour, depending
14on the quantity and density of the load, to achieve sterilization of
15the entire load. Thermometers, thermocouples, or other monitoring
16devices identified in the facility operating plan shall be checked
17for calibration annually. Records of the calibration checks shall
18be maintained as part of the facility’s files and records for a period
19of two years or for the period specified in the regulations.

20(C) Heat-sensitive tape, or another method acceptable to the
21enforcement agency, shall be used on each biohazard bag or sharps
22container that is processed onsite to indicate that the waste went
23through heat treatment. If the biohazard bags or sharps containers
24are placed in a large liner bag within the autoclave for treatment,
25heat-sensitive tape or another method acceptable to the enforcement
26agency only needs to be placed on the liner bag and not on every
27hazardous waste bag or sharps container being treated.

28(D) The biological indicator Geobacillus stearothermophilus,
29or other indicator of adequate sterilization as approved by the
30department, shall be placed at the center of a load processed under
31standard operating conditions at least monthly to confirm the
32attainment of adequate sterilization conditions.

33(E) Records of the procedures specified in subparagraphs (A),
34(B), and (D) shall be maintained for a period of not less than two
35years.

36(3) (A) Other alternative medical waste treatment methods
37which are both of the following:

38(i) Approved by the department.

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

P37   1(B) Any alternative medical waste treatment method proposed
2to the department shall be evaluated by the department and either
3approved or rejected pursuant to the criteria specified in this
4subdivision.

5(b) Fluid blood or fluid blood products may be discharged to a
6public sewage system without treatment if its discharge is
7consistent with waste discharge requirements placed on the public
8sewage system by the California regional water quality control
9board with jurisdiction.

10(c) (1) A medical waste that is a biohazardous laboratory waste,
11as defined in subparagraph (B) of paragraph (1) of subdivision (b)
12of Section 117690, may be treated by a chemical disinfection if
13the waste is liquid or semiliquid and the chemical disinfection
14method is recognized by the National Institutes of Health, the
15Centers for Disease Control and Prevention, or the American
16Biological Safety Association, and if the use of chemical
17disinfection as a treatment method is identified in the site’s medical
18waste management plan.

19(2) If the waste is not treated by chemical disinfection, in
20accordance with paragraph (1), the waste shall be treated by one
21of the methods specified in subdivision (a).

22(3) Following treatment by chemical disinfection, the medical
23waste may be discharged to the public sewage system if the
24discharge is consistent with waste discharge requirements placed
25on the public sewage system by the California regional water
26control board, and the discharge is in compliance with the
27requirements imposed by the owner or operator of the public
28sewage system. If the chemical disinfection of the medical waste
29causes the waste to become a hazardous waste, the waste shall be
30managed in accordance with the requirements of Chapter 6.5
31(commencing with Section 25100) of Division 20.

32

begin deleteSEC. 72.end delete
33begin insertSEC. 71.end insert  

Section 118220 of the Health and Safety Code is
34amended to read:

35

118220.  

Pathology waste of a human nature, as defined in
36subparagraph (A) of paragraph (2) of subdivision (b) of Section
37117690, shall be disposed of by interment, incineration, or
38alternative treatment technologies approved to treat this type of
39waste, pursuant to paragraph (1) or paragraph (3) of subdivision
40(a) of Section 118215.

P38   1

begin deleteSEC. 73.end delete
2begin insertSEC. 72.end insert  

Section 118222 of the Health and Safety Code is
3amended to read:

4

118222.  

(a) Pathology waste that meets the conditions of
5paragraph (2) of subdivision (b) of Section 117690 and trace
6chemotherapy waste that meets the conditions of paragraph (5) of
7subdivision (b) of Section 117690 shall be treated by incineration
8or alternative treatment technologies approved to treat that waste
9pursuant to paragraph (1) or paragraph (3) of subdivision (a) of
10Section 118215 prior to disposal.

11(b) Pharmaceutical waste from health care settings that meets
12the conditions specified in paragraph (3) of subdivision (b) of
13Section 117690 shall be treated by incineration or alternative
14treatment technologies approved to treat that waste pursuant to
15paragraph (1) or paragraph (3) of subdivision (a) of Section 118215
16prior to disposal.

17

begin deleteSEC. 74.end delete
18begin insertSEC. 73.end insert  

Section 118240 of the Health and Safety Code is
19amended to read:

20

118240.  

Notwithstanding Section 9141 of the Food and
21Agricultural Code, animals that die from infectious diseases or
22that are euthanized because they are suspected of having been
23exposed to infectious disease shall be treated with a treatment
24technology approved by the department for that use if, in the
25opinion of the attending veterinarian or local health officer, the
26carcass presents a danger of infection to humans.

27

begin deleteSEC. 75.end delete
28begin insertSEC. 74.end insert  

Section 118245 of the Health and Safety Code is
29amended to read:

30

118245.  

The department shall charge an application fee for
31evaluation of an alternative treatment technology of two thousand
32five hundred dollars ($2,500) and shall charge an additional fee
33equal to one hundred dollars ($100) per hour for each hour which
34the department spends on processing the application, but not more
35than a total of five thousand dollars ($5,000), or as provided in the
36regulations adopted by the department, not to exceed the reasonable
37regulatory costs of the department.

38

begin deleteSEC. 76.end delete
39begin insertSEC. 75.end insert  

Section 118275 of the Health and Safety Code is
40amended to read:

P39   1

118275.  

(a) To containerize or store medical waste, at the
2point of generation and while collected in that room, a person shall
3do all of the following:

4(1) Medical waste, as defined in Section 117690, shall be
5contained separately from other waste at the point of origin in the
6producing facility. Sharps containers may be placed in biohazard
7bags or in containers with biohazard bags.

8(2) Biohazardous waste, as defined in paragraph (1) of
9subdivision (b) of Section 117690, shall be placed in a biohazard
10bag conspicuously labeled with the words “Biohazardous Waste”
11or with the international biohazard symbol and the word
12“BIOHAZARD.”

13(3) Sharps waste, as defined in paragraph (4) of subdivision (b)
14of Section 117690, including sharps and pharmaceutical waste
15containerized pursuant to paragraph (7), shall be contained in a
16United States Food and Drug Administration (USFDA) approved
17sharps container that meets USFDA labeling requirements and is
18handled pursuant to Section 118285.

19(4) Trace chemotherapy waste, as defined in paragraph (5) of
20subdivision (b) of Section 117690, shall be segregated for storage,
21and, when placed in a secondary container, that container shall be
22labeled with the words “Chemotherapy Waste,” “CHEMO,” or
23other label approved by the department on the lid and sides, so as
24to be visible from any lateral direction, to ensure treatment of the
25biohazardous waste pursuant to Section 118222. Sharps waste that
26is contaminated through contact with, or having previously
27contained, chemotherapeutic agents, shall be placed in sharps
28containers labeled in accordance with the industry standard with
29the words “Chemotherapy Waste,” “Chemo,” or other label
30approved by the department, and shall be segregated to ensure
31treatment of the sharps waste pursuant to Section 118222.

32(5)  Pathology waste, as defined in paragraph (2) of subdivision
33(b) of Section 117690, shall be segregated for storage and, when
34placed in a secondary container, that container shall be labeled
35with the words “Pathology Waste,” “PATH,” or other label
36approved by the department on the lid and sides, so as to be visible
37from any lateral direction, to ensure treatment of the waste pursuant
38to Section 118222.

39(6) Pharmaceutical waste, as defined in paragraph (3) of
40subdivision (b) of Section 117690, shall be segregated for storage
P40   1in accordance with the facility’s medical waste managementbegin delete plan
2to ensure that it is properly containerized for disposalend delete
begin insert plan. When
3this waste is prepared for shipment offsite for treatment, it shall
4be properly containerized for shipmentend insert
in compliance with United
5States Department of Transportation and United States Drug
6Enforcement Agency (DEA) requirements.

7(A) Pharmaceutical wastes classified by the DEA as “controlled
8substances” shall be disposed of in compliance with DEA
9requirements.

10(B) Nonradioactive pharmaceutical wastes that are not subject
11to the federal Resource Conservation and Recovery Act of 1976
12(Public Law 94-580), as amended, and that are regulated as medical
13waste are placed in a container or secondary container labeled with
14the wordsbegin delete “HIGH HEAT ONLY,” “INCINERATION,” or otherend delete
15begin insert “HIGH HEAT OR INCINERATION ONLY,” or with anotherend insert label
16approved by thebegin delete departmentend deletebegin insert department,end insert on the lid and sides, so
17as to be visible from any lateral direction, to ensure treatment of
18the biohazardous waste pursuant to Section 118222.

19(7) A person may consolidate into a common container, which
20may be reusable, sharps waste, as defined in paragraph (4) of
21subdivision (b) of Section 117690, and pharmaceutical wastes, as
22defined in paragraph (3) of subdivision (b) of Section 117690,
23provided that both of the following apply:

24(A) The consolidated waste is treated by incineration or
25alternative treatment technologies approved to treat that waste
26pursuant to paragraph (1) or (3) of subdivision (a) of Section
27118215 prior to disposal. That alternative treatment shall render
28the waste unrecoverable and nonhazardous.

29(B) The container meets the requirements of Section 118285.
30The container shall be labeled with the biohazardous waste symbol
31and the wordsbegin delete “HIGH HEAT ONLY,” “INCINERATION,” or
32otherend delete
begin insert “HIGH HEAT OR INCINERATION ONLY,” or with anotherend insert
33 label approved by thebegin delete departmentend deletebegin insert department,end insert on the lid and sides,
34so as to be visible from any lateral direction, to ensure treatment
35of the waste pursuant to this subdivision.

36(b) To containerize medical waste being held for shipment
37offsite for treatment, the waste shall be labeled, as outlined in
38subdivision (a), on the lid and sides of the container.

P41   1(c) When medical waste is containerized pursuant to
2subdivisions (a) and (b) there is no requirement to label the
3containers with the date that the waste started to accumulate.

4

begin deleteSEC. 77.end delete
5begin insertSEC. 76.end insert  

Section 118280 of the Health and Safety Code is
6amended to read:

7

118280.  

To containerize biohazard bags, a person shall do all
8of the following:

9(a) The bags shall be tied to prevent leakage or expulsion of
10contents during all futurebegin delete storage, handling, or transport inend deletebegin insert storage
11and handling. When containers are prepared for transport offsite
12from the facility, they shall be prepared inend insert
compliance with United
13States Department of Transportation requirements.

14(b) (1) Medical waste may be placed into a biohazard bag not
15to exceed three pounds or one gallon and tied, as required in
16subdivision (a), in a patient room and shall be immediately
17transported upon completion of the procedure directly from the
18point of generation and placed into a biohazard container stored
19in a soiled utility room or other biohazardous waste storage area
20without having first been placed into a secondary container in the
21patient room.

22(2) Medical waste may be placed into a biohazard bag hung on
23a hamper stand in a surgery suite and the bag removed from the
24hamper stand after completion of the procedure, taken out of the
25surgery suite, and placed into a biohazard container stored in a
26soiled utility room or other biohazard waste storage area.

27(c) Biohazardous waste, except as provided in subdivision (b),
28shall be bagged in accordance with subdivision (b) of Section
29118275 and placed for storage, handling, or transport in a rigid
30container that may be disposable, reusable, or recyclable.
31Containers shall be leak resistant, have tight-fitting covers, and be
32kept clean and in good repair. Containers may be recycled with
33the approval of the enforcement agency. Containers may be of any
34color and shall be labeled with the words “Biohazardous Waste”
35or with the international biohazard symbol and the word
36“BIOHAZARD” on the lid and sides so as to be visible from any
37lateral direction. Containers shall comply with United States
38Department of Transportation requirementsbegin delete once in transit.end deletebegin insert when
39prepared for transport offsite from the facility.end insert

P42   1(d) Biohazardous waste shall not be removed from the biohazard
2bag until treatment as prescribed in Chapter 8 (commencing with
3Section 118215) is completed, except to eliminate a safety hazard,
4or by the enforcement officer in performance of an investigation
5pursuant to Section 117820. Biohazardous waste shall not be
6disposed of before being treated as prescribed in Chapter 8
7(commencing with Section 118215).

8(e) (1) Except as provided in paragraph (5), a person generating
9biohazardous waste shall comply with the following requirements:

10(A) If the person generates 20 or more pounds of biohazardous
11waste per month, the person shall not contain or store that waste
12above 0° Centigrade (32° Fahrenheit) at an onsite location for more
13than seven days without obtaining prior written approval of the
14enforcement agency.

15(B) If a person generates less than 20 pounds of biohazardous
16waste per month, the person shall not contain or store that waste
17above 0° Centigrade (32° Fahrenheit) at an onsite location for more
18than 30 days.

19(2) A person may store biohazardous waste at or below 0°
20Centigrade (32° Fahrenheit) at an onsite location for not more than
2190 days without obtaining prior written approval of the enforcement
22agency.

23(3) A person may store biohazardous waste at a permitted
24transfer station at or below 0° Centigrade (32° Fahrenheit) for not
25more than 30 days without obtaining prior written approval of the
26enforcement agency.

27(4) A person shall not store biohazardous waste above 0°
28Centigrade (32° Fahrenheit) at a location or facility that is offsite
29from the generator for more than seven days before treatment.

30(5) Notwithstanding paragraphs (1) to (4), inclusive, if the odor
31from biohazardous or sharps waste stored at a facility poses a
32nuisance, the enforcement agency may require more frequent
33removal.

34(f) Waste that meets the definition of pharmaceutical waste in
35paragraph (3) of subdivision (b) of Section 117690 shall not be
36subject to the limitations on storage time prescribed in subdivision
37(e). A person may store that pharmaceutical waste at an onsite
38location for not longer than 90 days when the container is ready
39for disposal, unless prior written approval from the enforcement
40agency is obtained. The container shall be emptied at least once
P43   1per year, unless prior written approval from the enforcement agency
2is obtained. A person may store that pharmaceutical waste at a
3permitted transfer station for not longer than 30 days without
4obtaining prior written approval from the enforcement agency. A
5person shall not store pharmaceutical waste at a location or facility
6that is offsite from the generator for more than 30 days before
7treatment.

8(g) The containment and storage time for wastes consolidated
9in a common container pursuant to paragraph (7) of subdivision
10(a) of Section 118275 shall not exceed the storage time for any
11category of waste set forth in this section.

12

begin deleteSEC. 78.end delete
13begin insertSEC. 77.end insert  

Section 118286 of the Health and Safety Code is
14amended to read:

15

118286.  

(a) A person shall not knowingly place
16home-generated sharps waste in any of the following containers:

17(1) Any container used for the collection of solid waste,
18recyclable materials, or greenwaste.

19(2) Any container used for the commercial collection of solid
20waste or recyclable materials from business establishments.

21(3) Any roll-off container used for the collection of solid waste,
22construction, and demolition debris, greenwaste, or other recyclable
23materials.

24(b) Home-generated sharps waste shall be transported only in
25a sharps container, or other containers approved by the enforcement
26agency, and shall only be managed at any of the following:

27(1) A household hazardous waste facility pursuant to Section
2825218.13.

29(2) A “home-generated sharps consolidation point” as defined
30in subdivision (b) of Section 117904.

31(3) A medical waste generator’s facility pursuant to Section
32118147.

33(4) A facility through the use of a medical waste mail-back
34container approved by the United States Postal Service.

35

begin deleteSEC. 79.end delete
36begin insertSEC. 78.end insert  

Section 118307 of the Health and Safety Code is
37amended to read:

38

118307.  

Medical waste that is stored in an area prior to transfer
39to the designated accumulation area, as defined in Section 118310,
40shall be stored in an area that is either locked or under direct
P44   1supervision or surveillance. Intermediate storage areas shall be
2marked with the international biohazard symbol or the signage
3described in Section 118310. These warning signs shall be readily
4legible from a distance of five feet. This section does not apply to
5the rooms in which medical waste is generated.

6

begin deleteSEC. 80.end delete
7begin insertSEC. 79.end insert  

Section 118321.1 of the Health and Safety Code is
8amended to read:

9

118321.1.  

(a) A trauma scene waste management practitioner
10shall register with the department on forms provided by the
11department.

12(b) The department shall register a trauma scene waste
13management practitioner and issue a trauma scene waste hauling
14permit to a trauma scene waste management practitioner who
15submits a completed application form and the registration fee,
16upon approval of the application by the department.

17(c) A registered trauma scene waste management practitioner
18is exempt from the registration requirements imposed pursuant to
19Chapter 6 (commencing with Section 118025) or Article 6.5
20(commencing with Section 25167.1) of Chapter 6.5 of Division
2120 upon haulers of medical waste.

22(d) Registered trauma scene waste management practitioners
23shall pay an annual fee of two hundred dollars ($200) to the
24department for deposit in the fund. The fee revenues deposited in
25the fund pursuant to this subdivision may be expended by the
26department, upon appropriation by the Legislature, for the
27implementation of this chapter.

28begin insert

begin insertSEC. 80.end insert  

end insert

begin insertSection 118321.5 of the end insertbegin insertHealth and Safety Codeend insertbegin insert is
29amended to read:end insert

30

118321.5.  

(a)  Trauma scene waste shall be removed from the
31trauma scene immediately upon completion of the removal phase
32of a trauma scene waste removal operation.

33(b) Trauma scene waste shall be transported to a permitted
34medical waste transfer station or treatment facility pursuant to
35subdivisionbegin delete (d)end deletebegin insert (a)end insert of Section 118000, or may be stored in a
36dedicated freezer at the business location of the trauma scene waste
37management practitioner for a period of not more than 14 days,
38or as otherwise approved by the department.

39

SEC. 81.  

Section 118335 of the Health and Safety Code is
40amended to read:

P45   1

118335.  

(a) In order to carry out the purpose of this part, any
2authorized representative of the enforcement agency may do any
3of the following:

4(1) Enter and inspect a facility for which a medical waste permit
5or registration has been issued, for which a medical waste permit
6or registration application has been filed, or that is subject to
7registration or permitting requirements pursuant to this part. Enter
8and inspect a vehicle for which a hazardous waste hauler
9registration has been issued, for which an application has been
10filed for a hazardous waste hauler registration, or that is subject
11to registration requirements pursuant to this part.

12(2) Inspect and copy any records, reports, test results, or other
13information related to the requirements of this part or the
14regulations adopted pursuant to this part.

15(b) The inspection shall be made with the consent of the owner
16or possessor of the facilities or, if consent is refused, with a warrant
17duly issued pursuant to Title 13 (commencing with Section
181822.50) of Part 3 of the Code of Civil Procedure. However, in
19the event of an emergency affecting the public health or safety, an
20inspection may be made without consent or the issuance of a
21warrant.

22(c) Any traffic officer, as defined in Section 625 of the Vehicle
23Code, and any peace officer, as defined in Section 830.1 or 830.2
24of the Penal Code, may enforce Chapter 6 (commencing with
25Section 118000) and this chapter, and for purposes of enforcing
26these chapters, traffic officers and these peace officers are
27authorized representatives of the department.

28

SEC. 82.  

Section 118345 of the Health and Safety Code is
29amended to read:

30

118345.  

(a) Any person who intentionally makes any false
31statement or representation in any application, label, shipping
32document,begin insert tracking document,end insert record, report, permit, registration,
33or other document filed, maintained, or used for purposes of
34compliance with this part that materially affects the health and
35safety of the public is liable for a civil penalty of not more than
36ten thousand dollars ($10,000) for each separate violation or, for
37continuing violations, for each day that the violation continues.

38(b) Any person who fails to register or fails to obtain a medical
39waste permit in violation of this part, or otherwise violates any
40provision of this part, any order issued pursuant to Section 118330,
P46   1or any regulation adopted pursuant to this part, is liable for a civil
2penalty of not more than ten thousand dollars ($10,000) for each
3violation of a separate provision of this part or, for continuing
4violations, for each day that the violation continues.

5

SEC. 83.  

No reimbursement is required by this act pursuant to
6Section 6 of Article XIII B of the California Constitution because
7the only costs that may be incurred by a local agency or school
8district will be incurred because this act creates a new crime or
9infraction, eliminates a crime or infraction, or changes the penalty
10for a crime or infraction, within the meaning of Section 17556 of
11the Government Code, or changes the definition of a crime within
12the meaning of Section 6 of Article XIII B of the California
13Constitution.



O

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