Amended in Assembly August 17, 2015

Amended in Assembly July 2, 2015

Amended in Assembly June 23, 2015

Amended in Assembly June 8, 2015

Senate BillNo. 225


Introduced by Senator Wieckowski

February 13, 2015


An act to amend Sections 117630,begin insert 117904, 117943, 117945, 117975, 118032, end insert118040,begin insert 118345,end insert and 118275 of the Health and Safety Code, relating to medical waste, and declaring the urgency thereof, to take effect immediately.

LEGISLATIVE COUNSEL’S DIGEST

SB 225, as amended, Wieckowski. Medical waste.

(1) begin deleteExisting end deletebegin insertUnder existing end insertlaw, the Medical Waste Management Act,begin insert the California Department of Public Healthend insert regulates the disposal of medicalbegin delete waste, including requiringend deletebegin insert waste. The act requiresend insert specified biohazard materials to be disposed of in biohazard bags andbegin delete requiringend deletebegin insert requiresend insert 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.” Existing law defines a biohazard bag to mean a film bag that is impervious to moisture. Existing law requires the film bags that are used for transport to be marked and certified by the manufacturer as having passed specified tests prescribed for tear resistance and for impact resistance.

This bill would revise the definition of “biohazard bag” and would limit the application of the requirement that film bags used for transport be marked and certified by the manufacturer as having passed specified tests only to those film bags that are used for transport from the generator’s facility onto roadways and into commerce to a treatment and disposal facility. The bill would revise the requirements for biohazard bags that are used to collect medical waste within a facility, as specified.

(2) Existing law requires a hazardous waste transporter or generator transporting medical waste to maintain a completed shipping document in compliance with the United States Department of Transportation and a tracking document if the waste is transported to a facility other than the final medical waste treatment facility.

This bill wouldbegin insert insteadend insert requirebegin delete a shipping document only whenend delete a hazardous waste transporterbegin insert thatend insert transports medical wastebegin delete on a public roadway.end deletebegin insert to maintain a tracking document in compliance with specified requirements for purposes of tracking medical waste from the point when the waste leaves the generator facility until the waste receives final treatment.end insert The bill would also require thebegin delete shipping document andend delete trackingbegin delete informationend deletebegin insert documentend insert to be maintained only by hazardous waste transporters, and not by generators transporting waste.begin insert The bill would also make conforming changes.end insert

This bill would declare that it is to take effect immediately as an urgency statute.

Vote: 23. Appropriation: no. Fiscal committee: yes. State-mandated local program: no.

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

P2    1

SECTION 1.  

Section 117630 of the Health and Safety Code
2 is amended to read:

3

117630.  

(a) “Biohazard bag” means a disposable film bag
4used to contain medical waste. Notwithstanding subdivision (b)
5of Section 117605, the film bags that are used to line the United
6States Department of Transportation (USDOT)-approved shipping
7containers for transport from the generator’s facility onto roadways
8and into commerce to a treatment and disposal facility shall be
9marked and certified by the manufacturer as having passed the
10tests prescribed for tear resistance in the American Society for
11Testing Materials (ASTM) D1922, “Standard Test Method for
P3    1Propagation Tear Resistance of Plastic Film and Thin Sheeting by
2Pendulum Method” and for impact resistance in ASTM D1709,
3“Standard Test Methods for Impact Resistance of Plastic Film by
4the Free-Falling Dart Method,” as those documents were published
5on January 1, 2014. The film bag shall meet an impact resistance
6of 165 grams and a tearing resistance of 480 grams in both parallel
7and perpendicular planes with respect to the length of the bag.

8(b) The biohazard bag that is used to collect medical waste
9within a facility shall be manufacturer certified to meet the ASTM
10D1709 dart drop test, provided that when the bag is prepared for
11transport offsite, it is placed into a USDOT-approved container
12lined with a biohazard bag that is ASTM D1709 and ASTM D1922
13certified.

14(c) The color of the bag shall be red, except when yellow bags
15are used to further segregate trace chemotherapy waste and white
16bags are used to further segregate pathology waste. The biohazard
17bag shall be marked with the international biohazard symbol and
18may be labeled by reference as authorized by the USDOT.

19begin insert

begin insertSEC. 2.end insert  

end insert

begin insertSection 117904 of the end insertbegin insertHealth and Safety Codeend insertbegin insert is
20amended to read:end insert

21

117904.  

(a) In addition to the consolidation points authorized
22pursuant to Section 118147, the enforcement agency may approve
23a location as a point of consolidation for the collection of
24home-generated sharps waste, which, after collection, shall be
25transported and treated as medical waste.

26(b) A consolidation location approved pursuant to this section
27shall be known as a “home-generated sharps consolidation point.”

28(c) A home-generated sharps consolidation point is not subject
29to the requirements of Chapter 9 (commencing with Section
30118275), to the permit or registration requirements of this part, or
31to any permit or registration fees, with regard to the activity of
32consolidating home-generated sharps waste pursuant to this section.

33(d) A home-generated sharps consolidation point shall comply
34with all of the following requirements:

35(1) All sharps waste shall be placed in sharps containers.

36(2) Sharps containers ready for disposal shall not be held for
37more than seven days without the written approval of the
38 enforcement agency.

39(e) An operator of a home-generated sharps consolidation point
40approved pursuant to this section shall not be considered the
P4    1generator of that waste, but shall be listed on thebegin delete shipping documentend delete
2begin insert tracking documentsend insert in compliance withbegin delete United States Department
3of Transportation andend delete
begin insert theend insert United States Postal Service
4begin delete requirements.end deletebegin insert requirements for waste shipped through mail back
5and on the tracking documents as required by the department.end insert

6(f) The medical waste treatment facility which treats the sharps
7waste subject to this section shall maintain thebegin delete shipping andend delete
8 trackingbegin delete documentsend deletebegin insert documentend insert required by Sections 118040 and
9118165 with regard to that sharps waste.

10begin insert

begin insertSEC. 3.end insert  

end insert

begin insertSection 117943 of the end insertbegin insertHealth and Safety Codeend insertbegin insert is
11amended to read:end insert

12

117943.  

(a) A medical waste generator required to register
13pursuant to this chapter shall maintain for a minimum of three
14years individual treatment operating records, and if applicable,
15begin delete shipping andend deletebegin insert theend insert trackingbegin delete documentsend deletebegin insert documentend insert for all untreated
16medical waste shipped offsite for treatment, and shall report or
17submit to the enforcement agency, upon request, all of the
18following:

19(1) Treatment operating records. Operating records shall be
20maintained in written or electronic form.

21(2) An emergency action plan complying with regulations
22adopted by the department.

23(3)  begin deleteShipping and tracking end delete begin insertTracking end insertdocuments or electronically
24archivedbegin delete shipping andend delete tracking documents maintained by the
25facility and medical waste hauler of all untreated medical waste
26shipped offsite for treatment.

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

29begin insert

begin insertSEC. 4.end insert  

end insert

begin insertSection 117945 of the end insertbegin insertHealth and Safety Codeend insertbegin insert is
30amended to read:end insert

31

117945.  

(a) Small quantity generators who are not required
32to register pursuant to this chapter shall maintain on file in their
33office all of following:

34(1) An information document stating how the generator contains,
35stores, treats, and disposes of any medical waste generated through
36any act or process of the generator.

37(2) Records required bybegin delete the United States Department of
38Transportation orend delete
the United States Postal Service of any medical
39waste shipped offsite for treatment and disposal. The small quantity
40generator shall maintain, or have available electronically at the
P5    1facility or from the medical waste hauler or common carrier, these
2records, for not less than three years.

3(b) Documentation shall be made available to the enforcement
4agency onsite.

5begin insert

begin insertSEC. 5.end insert  

end insert

begin insertSection 117975 of the end insertbegin insertHealth and Safety Codeend insertbegin insert is
6amended to read:end insert

7

117975.  

(a) A large quantity medical waste generator required
8to register pursuant to this chapter shall maintain for a minimum
9of two years individual treatment records andbegin delete shipping andend deletebegin insert theend insert
10 trackingbegin delete documentsend deletebegin insert documentend insert for all untreated medical waste
11shipped offsite for treatment. The generator shall report or submit
12to the enforcement agency, upon request, all of the following:

13(1) Treatment operating records. Operating records shall be
14maintained in written or electronic form.

15(2) An emergency action plan in accordance with regulations
16adopted by the department.

17(3)  begin deleteShipping and tracking end delete begin insertTracking end insertdocuments or electronically
18archivedbegin delete shipping andend delete trackingbegin delete documentsend deletebegin insert documentsend insert maintained
19by the facility or medical waste hauler of all untreated medical
20wastes shipped offsite for treatment.

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

24begin insert

begin insertSEC. 6.end insert  

end insert

begin insertSection 118032 of the end insertbegin insertHealth and Safety Codeend insertbegin insert is
25amended to read:end insert

26

118032.  

A pharmaceutical waste generator or parent
27organization that employs health care professionals who generate
28pharmaceutical waste is exempt from the requirements of
29subdivision (a) of Section 118000 if all of the following
30requirements are met:

31(a) The generator or parent organization has on file one of the
32following:

33(1) If the generator or parent organization is a small quantity
34generator required to register pursuant to Chapter 4 (commencing
35with Section 117925), a medical waste management plan prepared
36pursuant to Section 117935.

37(2) If the generator or parent organization is a small quantity
38generator not required to register pursuant to Chapter 4
39 (commencing with Section 117925), the information document
40maintained pursuant to subdivision (a) of Section 117945.

P6    1(3) If the generator or parent organization is a large quantity
2generator, a medical waste management plan prepared pursuant
3to Section 117960.

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

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

14(1) Prior to shipment of the pharmaceutical waste, the generator
15notifies the intended destination facility that it is shipping
16pharmaceutical waste to it and provides a copy of thebegin delete shipping andend delete
17 trackingbegin delete documents,end deletebegin insert document,end insert as specified in Section 118040.

18(2) The generator and the facility receiving the pharmaceutical
19waste maintain thebegin delete shipping andend delete trackingbegin delete documents,end deletebegin insert document,end insert
20 as specified in Section 118040.

21(3) The facility receiving the pharmaceutical waste notifies the
22generator of the receipt of the pharmaceutical waste shipment and
23any discrepancies between the items received and thebegin delete shipping
24andend delete
trackingbegin delete documents,end deletebegin insert document,end insert as specified in Section 118040,
25evidencing diversion of the pharmaceutical waste.

26(4) The generator notifies the enforcement agency of any
27discrepancies between the items received and thebegin delete shipping andend delete
28 trackingbegin delete documents,end deletebegin insert document,end insert as specified in Section 118040,
29evidencing diversion of the pharmaceutical waste.

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

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

39(B) The number of containers of pharmaceutical waste. This
40clause does not require any generator to maintain a separate
P7    1pharmaceutical waste container for every patient or to maintain
2records as to the specified source of the pharmaceutical waste in
3any container.

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

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

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

13

begin deleteSEC. 2.end delete
14begin insertSEC. 7.end insert  

Section 118040 of the Health and Safety Code is
15amended to read:

16

118040.  

(a)  Except with regard to sharps waste consolidated
17by a home-generated sharps consolidation point approved pursuant
18to Section 117904, a hazardous waste transporter transporting
19medical waste shall maintain a completedbegin delete shippingend deletebegin insert trackingend insert
20 document in compliance withbegin delete United States Department of
21Transportation (USDOT) requirements when medical waste is
22transported on a public roadway. In addition to the shipping
23document required by USDOT, a hazardous waste transporter who
24transports medical waste to a facility, other than the final medical
25waste treatment facility, shall also maintain tracking information
26that shows the name, address, and telephone number of the medical
27waste generator, for purposes of tracking the generator of medical
28waste when the waste is transported to the final medical waste
29treatment facility.end delete
begin insert subdivision (b) for the purpose of tracking the
30medical waste from the point when the waste leaves the generator
31facility until it receives final treatment.end insert
At the time that the medical
32waste is received by a hazardous waste transporter, the transporter
33shall provide the medical waste generator with a copy of the
34begin delete shipping document and tracking document, if the waste is
35transported to a facility other than the final medical waste treatment
36facility for the generator’s medical waste records. Information
37from the shipping document and the tracking document may be
38combined onto one form having the required information.end delete
begin insert tracking
39document.end insert
The transporter transporting medical waste shall
P8    1maintain its copy of thebegin delete shipping, tracking, and combined
2documentsend delete
begin insert tracking documentend insert for three years.

3(b)  The tracking document shall include, but not be limited to,
4all of the following information:

5(1)  The name, address, telephone number, and registration
6number of the transporter, unless transported pursuant to Section
7117946 or 117976.

8(2)  The type of medical waste transported and the quantity or
9aggregate weight of medical waste transported.

10(3)  The name, address, and telephone number of the generator.

11(4)  The name, address, telephone number, permit number, and
12the signature of an authorized representative of the permitted
13facility receiving the medical waste.

14(5)  The date that the medical waste is collected or removed
15from the generator’s facility, the date that the medical waste is
16received by the transfer station, the registered large quantity
17generator, or point of consolidation, if applicable, and the date that
18the medical waste is received by the treatment facility.

19(c)  A hazardous waste transporterbegin delete or generatorend delete transporting
20medical waste in a vehicle shall have thebegin delete shipping and tracking
21documentsend delete
begin insert tracking documentend insert in his or her possession while
22transporting the medical waste. The tracking document shall be
23shown upon demand to any enforcement agency personnel or
24officer of the Department of the California Highway Patrol. If the
25medical waste is transported by rail, vessel, or air, the railroad
26corporation, vessel operator, or airline shall enter on the shipping
27papers any information concerning the medical waste that the
28enforcement agency may require.

29(d)  A hazardous waste transporterbegin delete or a generatorend delete transporting
30medical waste shall provide the facility receiving the medical waste
31with the originalbegin delete shipping and tracking documents.end deletebegin insert tracking
32document.end insert

33(e)  Each hazardous waste transporter and each medical waste
34treatment facility shall provide tracking data periodically and in a
35format as determined by the department.

36

begin deleteSEC. 3.end delete
37begin insertSEC. 8.end insert  

Section 118275 of the Health and Safety Code is
38amended to read:

P9    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 and labeled in compliance with Section 117630.

11(3) Sharps waste, as defined in paragraph (4) of subdivision (b)
12of Section 117690, including sharps and pharmaceutical waste
13containerized pursuant to paragraph (7), shall be contained in a
14United States Food and Drug Administration (USFDA) approved
15sharps container that meets USFDA labeling requirements and is
16handled pursuant to Section 118285.

17(4) Trace chemotherapy waste, as defined in paragraph (5) of
18subdivision (b) of Section 117690, shall be segregated for storage,
19and, when placed in a secondary container, that container shall be
20labeled with the words “Chemotherapy Waste,” “CHEMO,” or
21other label approved by the department on the lid and sides, so as
22to be visible from any lateral direction, to ensure treatment of the
23biohazardous waste pursuant to Section 118222. Sharps waste that
24is contaminated through contact with, or having previously
25contained, chemotherapeutic agents, shall be placed in sharps
26containers labeled in accordance with the industry standard with
27the words “Chemotherapy Waste,” “CHEMO,” or other label
28approved by the department, and shall be segregated to ensure
29treatment of the sharps waste pursuant to Section 118222.

30(5)  Pathology waste, as defined in paragraph (2) of subdivision
31(b) of Section 117690, shall be segregated for storage and, when
32placed in a secondary container, that container shall be labeled
33with the words “Pathology Waste,” “PATH,” or other label
34approved by the department on the lid and sides, so as to be visible
35from any lateral direction, to ensure treatment of the waste pursuant
36to Section 118222.

37(6) Pharmaceutical waste, as defined in paragraph (3) of
38subdivision (b) of Section 117690, shall be segregated for storage
39 in accordance with the facility’s medical waste management plan.
40When this waste is prepared for shipment offsite for treatment, it
P10   1shall be properly containerized for shipment in compliance with
2United States Department of Transportation and the United States
3Drug Enforcement Administration (DEA) requirements.

4(A) Pharmaceutical wastes classified by the DEA as “controlled
5substances” shall be disposed of in compliance with DEA
6requirements.

7(B) Nonradioactive pharmaceutical wastes that are not subject
8to the federal Resource Conservation and Recovery Act of 1976
9(Public Law 94-580), as amended, and that are regulated as medical
10waste are placed in a container or secondary container labeled with
11the words “HIGH HEAT” or “INCINERATION ONLY,” or with
12another label approved by the department, on the lid and sides, so
13as to be visible from any lateral direction, to ensure treatment of
14the biohazardous waste pursuant to Section 118222.

15(7) A person may consolidate into a common container, which
16may be reusable, sharps waste, as defined in paragraph (4) of
17subdivision (b) of Section 117690, and pharmaceutical wastes, as
18defined in paragraph (3) of subdivision (b) of Section 117690,
19provided that both of the following apply:

20(A) The consolidated waste is treated by incineration or
21alternative treatment technologies approved to treat that waste
22 pursuant to paragraph (1) or (3) of subdivision (a) of Section
23118215 prior to disposal. That alternative treatment shall render
24the waste unrecoverable and nonhazardous.

25(B) The container meets the requirements of Section 118285.
26The container shall be labeled with the biohazardous waste symbol
27and the words “HIGH HEAT” or “INCINERATION ONLY,” or
28with another label approved by the department, on the lid and
29sides, so as to be visible from any lateral direction, to ensure
30treatment of the waste pursuant to this subdivision.

31(b) To containerize medical waste being held for shipment
32offsite for treatment, the waste shall be labeled, as outlined in
33subdivision (a), on the lid and sides of the container.

34(c) When medical waste is containerized pursuant to
35subdivisions (a) and (b) there is no requirement to label the
36 containers with the date that the waste started to accumulate.

37begin insert

begin insertSEC. 9.end insert  

end insert

begin insertSection 118345 of the end insertbegin insertHealth and Safety Codeend insertbegin insert is
38amended to read:end insert

39

118345.  

(a) Any person who intentionally makes any false
40statement or representation in any application, label,begin delete shipping
P11   1document,end delete
tracking document, record, report, permit, registration,
2or other document filed, maintained, or used for purposes of
3compliance with this part that materially affects the health and
4safety of the public is liable for a civil penalty of not more than
5ten thousand dollars ($10,000) for each separate violation or, for
6continuing violations, for each day that the violation continues.

7(b) Any person who fails to register or fails to obtain a medical
8waste permit in violation of this part, or otherwise violates any
9provision of this part, any order issued pursuant to Section 118330,
10or any regulation adopted pursuant to this part, is liable for a civil
11penalty of not more than ten thousand dollars ($10,000) for each
12violation of a separate provision of this part or, for continuing
13violations, for each day that the violation continues.

14

begin deleteSEC. 4.end delete
15begin insertSEC. 10.end insert  

This act is an urgency statute necessary for the
16immediate preservation of the public peace, health, or safety within
17the meaning of Article IV of the Constitution and shall go into
18immediate effect. The facts constituting the necessity are:

19In order to ensure that necessary and technical changes to the
20laws governing the handling and disposal of medical waste are
21implemented as soon as possible, it is necessary that this act take
22effect immediately.



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