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. Public Health Impact Report.

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 Epidemicbegin delete Protectionend deletebegin insert Preventionend insert Act of 2013, would require the department to require the manufacturerbegin insert or a group of manufacturersend insert of a contributing product, as defined, to create, for approval of the department, a public health impact report (PHIR) containing specified information, including a list of adverse public health impacts and a mitigation plan for those impacts.begin insert The bill would require the manufacturer to mitigate the fiscal impacts on the state public health system over a reasonable period of time.end insert The bill would authorize the department to enforce the PHIR and would authorize the department to restrictbegin delete or suspendend delete 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. The bill would authorize the department to charge the manufacturer of the product for the reasonable costs of reviewing, approving, and enforcing the PHIR requirements.

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:

29 

30Article 6.  Public Health Impact Assessments
31

 

32

108670.  

This article shall be known, and may be cited, as the
33Public Health Epidemicbegin delete Protectionend deletebegin insert Preventionend insert Act of 2013.

34

108671.  

For the purposes of this article, the following
35definitions shall apply:

P3    1(a) “Contributing product” means abegin insert manufacturedend insert product
2intended for consumer consumption in this state for which the
3department has credible evidence that use of the product
4significantly contributes to a public health epidemic and that meets
5both of the following criteria:

6(1) The public health epidemic to which the product contributes
7is one recognized by the federal Centers for Disease Control and
8Preventionbegin insert, the United States Department of Health and Human
9Services, the Surgeon General, or the United States Food and
10Drug Administrationend insert
.

11(2) The adverse impact on public health from use of the product
12in this state would have a fiscal impact of fifty million dollars
13($50,000,000) or more annuallybegin insert on the state public health system,
14including, but not limited to, public hospitalsend insert
begin insert and overall Medi-Cal
15expendituresend insert
.

16(b) “Credible evidence” meansbegin insert peerend insertbegin insert-reviewedend insert research, data,
17and studies currently available to the department.

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

begin insert

19(d) “Manufacturer” means the manufacturer that created the
20public health impact report or, if the public health impact report
21was created by a group of the largest manufacturers, every
22manufacturer that participated in the study and submitted the
23report to the department.

end insert
24

108672.  

(a) If the department determines that a product is a
25contributing productbegin insert,end insert then the department shall require the
26begin insert contributingend insert product’sbegin delete manufacturerend deletebegin insert largest manufacturers,
27representing 80 percent of the costs identified in subdivision (a)
28and that do business in the state,end insert
to create a public health impact
29report (PHIR). The PHIR shall be submitted to the department for
30 approval.begin insert As appropriate, the department may grant permission
31for the contributing productend insert
begin insert’s largest manufacturers to participate
32in one study and submit one PHIR to the department for approval.end insert

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

34(1) A list of adverse public health impacts that cannot be avoided
35if the product is sold in the state.

36(2) The benefits, costs, and alternatives to the contributing
37product.

38(3) Alternatives available, if any.

P4    1(4) A mitigation plan sufficient tobegin delete minimizeend deletebegin insert reasonably reduceend insert
2 the adverse public health impacts identified in paragraph (1)begin insert, to
3be implemented by the manufacturerend insert
.

begin insert

4(c) The manufacturer shall mitigate the adverse public health
5fiscal impacts on the state’s health system over a reasonable period
6of time. The mitigation plan shall consider and prioritize the most
7cost-effective mitigation.

end insert
begin insert

8(d) In preparing the mitigation plan, manufacturers may create
9and fund an advisory committee to make recommendations.

end insert
begin delete

15 10(c) The

end delete

11begin insert(e)end insertbegin insertend insertbegin insertPrior to approval or rejection of the PHIR, the department
12shall report to the respective Senate and Assembly committees on
13health and budget. end insert
begin insertTheend insert department may take actions necessary to
14enforce the PHIR, including, but not limited to, requiring that the
15manufacturer establish a trust or place moneys in escrow sufficient
16to cover the estimated costs of implementation.

begin delete

19 17(d)

end delete

18begin insert(f)end insert If the department determines that the PHIR prepared by the
19manufacturer is insufficient or that the manufacturer is not
20complying with the terms of the PHIR, then the department may
21restrictbegin delete or prohibitend delete the sale of the product in this statebegin insert, as
22appropriateend insert
.

23

108673.  

The department shall enact all regulations necessary
24to implement this article pursuant to the Administrative Procedure
25Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of
26Division 3 of Title 2 of the Government Code).

27

108674.  

The department may charge the manufacturer of the
28product for the reasonable costs of reviewing, approving, and
29enforcing the PHIR requirements. Fees collected pursuant to this
30subdivision shall be placed in the Public Health Fund, which is
31hereby established in the State Treasury and which may be used
32by the department, upon appropriation by the Legislature, for the
33implementation of this article.

34

108675.  

Notwithstanding subdivision (c) of Section 25257.1,
35the requirements of this article shall not be interpreted to affect
36any authority of the Department of Toxic Substances Control
37pursuant to Article 14 (commencing with Section 25251) of
38Chapter 6.5 of Division 20.



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