Amended in Senate January 6, 2014

Amended in Senate April 23, 2013

Amended in Senate April 15, 2013

Senate BillNo. 747


Introduced by Senator DeSaulnier

February 22, 2013


An act to add Article 6 (commencing with Section 108670) to Chapter 5 of Part 3 of Division 104 of the Health and Safety Code, relating to public health.

LEGISLATIVE COUNSEL’S DIGEST

SB 747, as amended, DeSaulnier. Publicbegin delete Health Impact Reportend deletebegin insert health iend insertbegin insertmpact assessmentsend insert.

Existing law requires the State Department of Public Health to regulate various consumer products, including food and drugs, for the protection of the people of the state.

This bill, known as the Public Health Epidemic Prevention Act ofbegin delete 2013,end deletebegin insert 2014,end insert wouldbegin delete requireend deletebegin insert authorizeend insert the department tobegin delete requireend deletebegin insert submit a written request toend insert the manufacturer or a group of manufacturers of a contributing product, as defined, tobegin delete create, for approval of the department, a public health impact report (PHIR) containingend deletebegin insert submit a written response to the department’s determination that the product is a contributing product. The bill would require the written response to containend insert specified information, including abegin delete listend deletebegin insert risk assessmentend insert of adverse public health impacts and a mitigation plan for those impacts.begin delete The bill would require the manufacturer to mitigate the fiscal impacts on the state public health system over a reasonable period of time. The bill would authorize the department to enforce the PHIR and would authorize the department to restrict sales of the product in the state if the PHIR is insufficient or if the manufacturer is not complying with the terms of the PHIR.end delete The bill would authorize the department to charge the manufacturer of thebegin insert contributingend insert productbegin insert an amount not exceeding $20,000end insert for the reasonable costs ofbegin delete reviewing, approving, and enforcing the PHIR requirementsend deletebegin insert reviewing the risk assessment and mitigation documentend insert.

Vote: majority. 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.  

The Legislature finds and declares all of the
2following:

3(a) Public health for the people of the state is now, and in the
4future, a matter of statewide concern.

5(b) The health and well-being of all people is a critical element
6in supporting a healthy and prosperous California, including
7economic sustainability, increasing workforce participation and
8productivity, and slowing the ongoing rise of medical care
9expenditures.

10(c) California and its residents face a growing burden of largely
11preventable chronic illness, including heart disease, stroke, obesity,
12and diabetes.

13(d) It is the intent of the Legislature to find ways to develop and
14maintain public health, prevent negative public health risks, provide
15the people of the state with protection from products sold in the
16state that pose significant negative health risks, and develop
17mitigation strategies.

18(e) It is the intent of the Legislature to take immediate steps to
19identify products sold in the state for consumer consumption that
20pose a critical public health risk and coordinate any actions
21necessary to prevent or mitigate those risks.

22(f) It is the intent of the Legislature to regulate products sold in
23the state for consumer consumption that pose significant public
24health risks and mitigate their use in order to prevent chronic illness
25and improve public health.

26

SEC. 2.  

Article 6 (commencing with Section 108670) is added
27to Chapter 5 of Part 3 of Division 104 of the Health and Safety
28Code
, to read:

 

P3    1Article 6.  Public Health Impact Assessments
2

 

3

108670.  

This article shall be known, and may be cited, as the
4Public Health Epidemic Prevention Act ofbegin delete 2013end deletebegin insert 2014end insert.

5

108671.  

For the purposes of this article, the following
6definitions shall apply:

7(a) “Contributing product” means a manufactured product
8intended for consumer consumption in this state for which the
9department has credible evidence that use of the product
10significantly contributes to a public health epidemic and that meets
11both of the following criteria:

12(1) The public health epidemic to which the product contributes
13is one recognized by the federal Centers for Disease Control and
14Prevention, the United States Department of Health and Human
15Services, the Surgeon General, or the United States Food and Drug
16Administration.

17(2) The adverse impact on public health from use of the product
18in this state would have a fiscal impact of fifty million dollars
19($50,000,000) or more annually on the state public health system,
20including, but not limited to, public hospitals and overall Medi-Cal
21expenditures.

22(b) “Credible evidence” means peer-reviewed research, data,
23and studies currently available to the department.

24(c) “Department” means the State Department of Public Health.

25(d) “Manufacturer” means the manufacturerbegin delete that created the
26public health impact report or, if the public health impact report
27was created by a group of the largest manufacturers, every
28manufacturer that participated in the study and submitted the report
29to the departmentend delete
begin insert whose name appears on the label of a product
30that is identified by the department as a contributing productend insert
.

31

108672.  

begin delete(a)end deletebegin deleteend deleteIf the department determines that a product is a
32contributing product, then the departmentbegin delete shall requireend deletebegin insert may submit
33a written request toend insert
the contributing product’s largest
34manufacturers, representing 80 percent of the costs identified in
35begin insert paragraph (2) ofend insert subdivision (a)begin insert of Section 108671end insert and that do
36business in the state, to begin delete create a public health impact report (PHIR).
37The PHIR shall be submitted to the department for approval. As
38appropriate, the department may grant permission for the
39contributing product’s largest manufacturers to participate in one
40study and submit one PHIR to the department for approval.end delete
begin insert submit
P4    1a written response to the department’s determination that the
2product is a contributing product. The written response shall
3include, but not be limited to, all of the following:end insert

begin insert

4(1) A written risk assessment analysis that identifies the public
5health impacts resulting from the sale of the product in this state.

end insert
begin insert

6(b) A list of mitigation strategies sufficient to reasonably reduce
7adverse public health impacts identified in the risk assessment.

end insert
begin delete

8(b) The PHIR shall include all of the following:

9(1) A list of adverse public health impacts that cannot be avoided
10if the product is sold in the state.

11(2) The benefits, costs, and alternatives to the contributing
12product.

13(3) Alternatives available, if any.

14(4) A mitigation plan sufficient to reasonably reduce the adverse
15public health impacts identified in paragraph (1), to be implemented
16by the manufacturer.

17(c) The manufacturer shall mitigate the adverse public health
18fiscal impacts on the state’s health system over a reasonable period
19of time. The mitigation plan shall consider and prioritize the most
20cost-effective mitigation.

21(d) In preparing the mitigation plan, manufacturers may create
22and fund an advisory committee to make recommendations.

23(e) Prior to approval or rejection of the PHIR, the department
24shall report to the respective Senate and Assembly committees on
25health and budget. The department may take actions necessary to
26enforce the PHIR, including, but not limited to, requiring that the
27manufacturer establish a trust or place moneys in escrow sufficient
28to cover the estimated costs of implementation.

29(f) If the department determines that the PHIR prepared by the
30manufacturer is insufficient or that the manufacturer is not
31complying with the terms of the PHIR, then the department may
32restrict the sale of the product in this state, as appropriate.

end delete
33

108673.  

The departmentbegin delete shallend deletebegin insert mayend insert enact all regulations
34necessary to implement this article pursuant to the Administrative
35Procedure Act (Chapter 3.5 (commencing with Section 11340) of
36Part 1 of Division 3 of Title 2 of the Government Code).

37

108674.  

The department may charge the manufacturer of the
38begin insert contributingend insert productbegin insert an amount not exceeding twenty thousand
39dollars ($20,000)end insert
for the reasonable costs ofbegin delete reviewing, approving,
40and enforcing the PHIR requirementsend delete
begin insert reviewing the risk assessment
P5    1and mitigation document submitted pursuant to Section 108672end insert
.
2Fees collected pursuant to this subdivision shall be placed in the
3Public Health Fund, which is hereby established in the State
4Treasury and which may be used by the department, upon
5appropriation by the Legislature, for the implementation of this
6article.

7

108675.  

Notwithstanding subdivision (c) of Section 25257.1,
8the requirements of this article shall not be interpreted to affect
9any authority of the Department of Toxic Substances Control
10pursuant to Article 14 (commencing with Section 25251) of
11Chapter 6.5 of Division 20.



O

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