SB 747 Senate Bill

BILL NUMBER: SB 747	AMENDED
	BILL TEXT

	AMENDED IN SENATE  JANUARY 6, 2014
	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   health i   mpact assessments  .
   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 of
 2013,   2014,  would  require
  authorize  the department to  require
  submit a written request to  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   submit a written
response to the department's determination that the product is a
contributing product. The bill would require the written response to
contain  specified information, including a  list
  risk assessment  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 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  contributing  product
 an amount not exceeding $20,000  for the reasonable costs
of  reviewing, approving, and enforcing the PHIR requirements
  reviewing the risk assessment and mitigation document
 .
   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 Prevention Act of  2013  
2014  .
   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   whose name appears on the label of a
product that is identified by the department as a contributing
product  .
   108672.   (a)    If the
department determines that a product is a contributing product, then
the department  shall require   may submit a
written request to  the contributing product's largest
manufacturers, representing 80 percent of the costs identified in
 paragraph (2) of  subdivision (a)  of Section 108671
 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.   submit a written response to the department'
s determination that the product is a contributing product. The
written response shall include, but not be limited to, all of the
following:  
   (1) A written risk assessment analysis that identifies the public
health impacts resulting from the sale of the product in this state.
 
   (b) A list of mitigation strategies sufficient to reasonably
reduce adverse public health impacts identified in the risk
assessment.  
   (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 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. 

   (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.  
   (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 the sale of the product in this state, as appropriate.

   108673.  The department  shall   may 
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 
contributing  product  an amount not exceeding twenty
thousand dollars ($20,000)  for the reasonable costs of 
reviewing, approving, and enforcing the PHIR requirements 
 reviewing the risk assessment and mitigation document submitted
pursuant to Section 108672  . 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.