BILL NUMBER: SB 747 AMENDED
BILL TEXT
AMENDED IN SENATE APRIL 23, 2013
AMENDED IN SENATE APRIL 15, 2013
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 Epidemic Protection
Prevention Act of 2013, would require the
department to require the manufacturer or a group of
manufacturers 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. 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 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. 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:
SECTION 1. The Legislature finds and declares all of the
following:
(a) Public health for the people of the state is now, and in the
future, a matter of statewide concern.
(b) The health and well-being of all people is a critical element
in supporting a healthy and prosperous California, including economic
sustainability, increasing workforce participation and productivity,
and slowing the ongoing rise of medical care expenditures.
(c) California and its residents face a growing burden of largely
preventable chronic illness, including heart disease, stroke,
obesity, and diabetes.
(d) It is the intent of the Legislature to find ways to develop
and maintain public health, prevent negative public health risks,
provide the people of the state with protection from products sold in
the state that pose significant negative health risks, and develop
mitigation strategies.
(e) It is the intent of the Legislature to take immediate steps to
identify products sold in the state for consumer consumption that
pose a critical public health risk and coordinate any actions
necessary to prevent or mitigate those risks.
(f) It is the intent of the Legislature to regulate products sold
in the state for consumer consumption that pose significant public
health risks and mitigate their use in order to prevent chronic
illness and improve public health.
SEC. 2. Article 6 (commencing with Section 108670) is added to
Chapter 5 of Part 3 of Division 104 of the Health and Safety Code, to
read:
Article 6. Public Health Impact Assessments
108670. This article shall be known, and may be cited, as the
Public Health Epidemic Protection Prevention
Act of 2013.
108671. For the purposes of this article, the following
definitions shall apply:
(a) "Contributing product" means a manufactured product
intended for consumer consumption in this state for which the
department has credible evidence that use of the product
significantly contributes to a public health epidemic and that meets
both of the following criteria:
(1) The public health epidemic to which the product contributes is
one recognized by the federal Centers for Disease Control and
Prevention , the United States Department of Health
and Human Services, the Surgeon General, or the United States Food
and Drug Administration .
(2) The adverse impact on public health from use of the product in
this state would have a fiscal impact of fifty million dollars
($50,000,000) or more annually on the state public health
system, including, but not limited to, public hospitals
and overall Medi-Cal expenditures .
(b) "Credible evidence" means peer -reviewed
research, data, and studies currently available to the department.
(c) "Department" means the State Department of Public Health.
(d) "Manufacturer" means the manufacturer that created the public
health impact report or, if the public health impact report was
created by a group of the largest manufacturers, every manufacturer
that participated in the study and submitted the report to the
department.
108672. (a) If the department determines that a product is a
contributing product , then the department shall require
the contributing product's manufacturer
largest manufacturers, representing 80 percent of the costs
identified in subdivision (a) and that do business in the state,
to create a public health impact report (PHIR). The PHIR shall
be submitted to the department for approval. As appropriate, the
department may grant permission for the contributing product
's largest manufacturers to participate in one study and submit
one PHIR to the department for approval.
(b) The PHIR shall include all of the following:
(1) A list of adverse public health impacts that cannot be avoided
if the product is sold in the state.
(2) The benefits, costs, and alternatives to the contributing
product.
(3) Alternatives available, if any.
(4) A mitigation plan sufficient to minimize
reasonably reduce the adverse public health impacts
identified in paragraph (1) , to be implemented by the
manufacturer .
(c) The manufacturer shall mitigate the adverse public health
fiscal impacts on the state's health system over a reasonable period
of time. The mitigation plan shall consider and prioritize the most
cost-effective mitigation.
(d) In preparing the mitigation plan, manufacturers may create and
fund an advisory committee to make recommendations.
(c) The
(e) Prior to approval or rejection of
the PHIR, the department shall report to the respective Senate and
Assembly committees on health and budget. The
department may take actions necessary to enforce the PHIR, including,
but not limited to, requiring that the manufacturer establish a
trust or place moneys in escrow sufficient to cover the estimated
costs of implementation.
(d)
(f) If the department determines that the PHIR prepared
by the manufacturer is insufficient or that the manufacturer is not
complying with the terms of the PHIR, then the department may
restrict or prohibit the sale of the product in
this state , as appropriate .
108673. The department shall enact all regulations necessary to
implement this article pursuant to the Administrative Procedure Act
(Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3
of Title 2 of the Government Code).
108674. The department may charge the manufacturer of the product
for the reasonable costs of reviewing, approving, and enforcing the
PHIR requirements. Fees collected pursuant to this subdivision shall
be placed in the Public Health Fund, which is hereby established in
the State Treasury and which may be used by the department, upon
appropriation by the Legislature, for the implementation of this
article.
108675. Notwithstanding subdivision (c) of Section 25257.1, the
requirements of this article shall not be interpreted to affect any
authority of the Department of Toxic Substances Control pursuant to
Article 14 (commencing with Section 25251) of Chapter 6.5 of Division
20.