SB 747, as introduced, 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 Epidemic Protection Act of 2013, would require the department, for every product intended for consumer consumption for which it has credible evidence that the product significantly contributes to a significant public epidemic, to conduct a risk assessment evaluation to determine whether the product contributes significantly to a significant public health epidemic, as defined, and whether the adverse public health risk would have a fiscal impact on the state of $50,000,000 or more. The bill would authorize the department to charge the manufacturer of the product for the reasonable costs of producing the risk assessment and would create the Public Health Fund, to be used by the department, upon appropriation by the Legislature, to fund the program. If the department determines that the criteria are met, the bill would require the manufacturer 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. The bill would authorize the department to enforce the PHIR and would authorize the department to restrict or suspend 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.
Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: no.
The people of the State of California do enact as follows:
The Legislature finds and declares all of the
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
10(c) California and its residents face a growing burden of largely
11preventable chronic illness, including heart disease, stroke, obesity,
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 development
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.
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:
This article shall be known, and may be cited, as the
33Public Health Epidemic Protection Act of 2013.
(a) The State Department of Public Health shall, for
2every product intended for consumer consumption that the
3department has credible evidence that the product significantly
4contributes to a significant public epidemic, conduct a risk
5assessment evaluation. The department, in doing the risk
6assessment evaluation, shall use currently available research, data,
7and studies to determine the following:
8(1) If the product contributes significantly to a significant public
9health epidemic, as recognized by the federal Centers for Disease
10Control and Prevention.
11(2) If there is evidence that the adverse public health risk would
12have a fiscal impact on the state of fifty million dollars
13 ($50,000,000) or more.
14(b) The department may charge the manufacturer of the product
15for the reasonable costs of producing the risk assessment pursuant
16to this section. Fees collected pursuant to this subdivision shall be
17placed in the Public Health Fund, which is hereby established in
18the State Treasury and which may be used by the department, upon
19appropriation by the Legislature, for the implementation of this
(a) If a risk assessment determines that the product
22meets both of the requirements in subdivision (a) of Section
23108671, the department shall require the product’s manufacturer
24to create a public health impact report (PHIR). The PHIR shall be
25submitted to the department for approval.
26(b) The PHIR shall include all of the following:
27(1) A list of adverse public health impacts that cannot be avoided
28if the product is sold in the state.
29(2) The benefits, costs, and alternatives to the consumer product.
30(3) Alternatives available, if any.
31(4) A mitigation plan sufficient to minimize the adverse public
32health impacts identified in paragraph (1).
33(c) The department may take actions necessary to enforce the
34PHIR, including, but not limited to, requiring that the manufacturer
35establish a trust or place moneys in escrow sufficient to cover the
36estimated costs of implementation.
37(d) If the department determines that the PHIR prepared by the
38manufacturer is insufficient or that the manufacturer is not
39complying with the terms of the PHIR, then the department may
40restrict or prohibit the sale of the product in this state.
The department shall enact all regulations necessary
2to implement this article pursuant to the Administrative Procedure
3Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of
4Division 3 of Title 2 of the Government Code).