2009 California Health and Safety Code - Section 110045-110135 :: Article 1. General

110045.  The department shall administer and enforce this part.

110050.  The Food Safety Fund is hereby created as a special fund in
the State Treasury. All moneys collected by the department under
subdivision (c) of Section 110466 and Sections 110470, 110471,
110485, and 111130, and under Article 7 (commencing with Section
110810) of Chapter 5 shall be deposited in the fund, for use by the
department, upon appropriation by the Legislature, for the purposes
of providing funds necessary to carry out and implement the
inspection provisions of this part relating to food, licensing,
inspection, enforcement, and other provisions of Article 12
(commencing with Section 111070) relating to water, the provisions
relating to education and training in the prevention of microbial
contamination pursuant to Section 110485, and the registration
provisions of Article 7 (commencing with Section 110810) of Chapter
5.

110055.  All money collected by the department under Sections
111830, 111885, and 111905 shall be deposited into the State Treasury
to the credit of the General Fund.

110060.  The director and authorized agents of the department shall
have the powers set forth in Sections 100165 and 106500.

110065.  The department may adopt any regulations that it determines
are necessary for the enforcement of this part. The regulations
shall be adopted by the department in the manner prescribed by
Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3
of Title 2 of the Government Code. The department shall, insofar as
practicable, make these regulations conform with those adopted under
the federal act or by the United States Department of Agriculture or
by the Internal Revenue Service of the United States Treasury
Department.

110070.  Whenever public health or other considerations in this
state require, the department may adopt, upon its own motion, or upon
the petition of any interested party, regulations that prescribe
tolerances, included but not limited to zero tolerances, for
poisonous or deleterious substances, food additives, pesticide
chemicals, or color additives. The department may also prescribe the
conditions under which a food additive or a color additive may be
safely used and may grant exemptions for a food additive or color
additive when it is to be used solely for investigational or
experimental purposes.
   A petitioner shall establish, by data submitted to the department,
that a necessity exists for such regulations and that its effect
will not be detrimental to the public health. If the data furnished
by the petitioner is not sufficient to allow the department to
determine whether such regulations should be adopted, the department
may require additional data to be submitted. Failure to comply with
this requirement shall be sufficient grounds to deny the request.

110075.  In adopting regulations, pursuant to Section 110070 of this
part, the department shall consider all of the following factors
that the petitioner shall furnish:
   (a) The name and all pertinent information concerning the
poisonous or deleterious substance, food additive, pesticide
chemical, or color additive, including its chemical identity and
composition, its proposed use, including directions, recommendations,
and suggestions, its proposed labeling, and all other relevant data
bearing on its physical or other technical effect, and the quantity
required to produce that effect.
   (b) The probable composition of any substance formed in or on a
food, drug, device, or cosmetic resulting from the use of the
substance.
   (c) The probable consumption and effect of the substance in the
diet of man or any other animal.
   (d) Safety factors that, in the opinion of qualified experts, are
generally recognized as appropriate for the use of animal
experimentation data.
   (e) Practicable methods of analysis for determining the identity
and quantity of all of the following:
   (1) Any substance which is in or on the food, drug, device, or
cosmetic.
   (2) Any substance formed in or on the food, drug, device, or
cosmetic because of the use of the substance.
   (3) The pure substance and its anticipated breakdown products and
impurities.
   (f) Facts supporting the contention that the use of the substance
will serve a useful purpose.

110080.  (a) All pesticide regulations and any amendments to these
regulations adopted pursuant to the federal act or the Food and
Agricultural Code, in effect on November 23, 1970, or adopted on or
after this date, are the pesticide regulations in this state. The
department may, by regulation, prescribe tolerances for pesticides in
processed foods in this state whether or not these tolerances are in
accordance with the regulations adopted pursuant to the federal act
or the Food and Agricultural Code.
   (b) Except as otherwise provided in this subdivision, the
department shall evaluate the tolerance prescribed, or an exemption
from a tolerance granted, for a pesticide in processed foods and make
a determination whether or not the existing tolerance, or the
exemption from a tolerance, is protective of the public health
whenever any one of the following occurs:
   (1) The Director of Food and Agriculture designates the pesticide
as a restricted material pursuant to subdivisions (a) and (b) of
Section 14004.5 of the Food and Agricultural Code.
   (2) The Director of Food and Agriculture refuses to register or
cancels the registration of the pesticide pursuant to Section 12825,
or suspends the registration of the pesticide pursuant to Section
12826, of the Food and Agricultural Code, upon determining that the
pesticide is detrimental to the public health and safety.
   (3) The Director of Food and Agriculture adopts regulations
restricting worker entry into areas treated with the pesticide
pursuant to Section 12981 of the Food and Agricultural Code.
   (4) The pesticide is the subject of a proceeding pursuant to a
determination by the Environmental Protection Agency under paragraph
(3)(i)(A), (3)(ii)(A), (3)(ii)(B), or (3)(iii) of subsection (a) of
Section 162.11 of Title 40 of the Code of Federal Regulations.
   The requirement to evaluate a tolerance prescribed, or an
exemption from a tolerance granted, for a pesticide does not apply if
the department finds that any of the actions described in paragraphs
(1) to (4), inclusive, occurred for reasons that are not related to
the question whether or not the existing tolerance, or the exemption
from a tolerance, adequately protects the public health. If the
department makes such a finding, the reasons for the finding shall be
stated in writing.
   (c) The determination required by subdivision (b), and the reasons
for the determination, shall be stated in writing. If the
determination is required because any of the actions described in
paragraphs (1) to (4), inclusive, of subdivision (b) occurs after
January 1, 1985, the determination shall be completed within one year
of the date of the action. If the determination is required because
any of those actions occurred prior to January 1, 1985, the
determination shall be completed by January 1, 1990.
   (d) In any case where the department, after consultation with the
Department of Food and Agriculture, determines, pursuant to
subdivision (b), that the tolerance prescribed, or an exemption from
a tolerance granted, for a pesticide is not protective of the public
health, the department shall, if it does not act immediately pursuant
to subdivision (a), transmit notice of its determination to the
responsible federal agencies and shall request that they take action,
pursuant to the federal act, to modify the tolerance or an exemption
from a tolerance. If, after one year from the date the notice is
transmitted, the department finds that the responsible federal
agencies have failed to take appropriate action to protect the public
health, the department shall exercise its authority pursuant to
subdivision (a) to prescribe a tolerance that is protective of the
public health and shall notify the responsible federal agencies of
its action.

110085.  All food additive regulations and any amendments to the
regulations adopted pursuant to the federal act in effect on November
23, 1970, or adopted on or after that date, are the food additive
regulations of this state. The department may, by regulation,
prescribe conditions under which a food additive may be used in this
state whether or not these conditions are in accordance with the
regulations adopted pursuant to the federal act.

110090.  All color additive regulations and any amendments to the
regulations adopted pursuant to the federal act, in effect on
November 23, 1970, or adopted on or after that date, are the color
additive regulations of this state. The department may, by
regulation, prescribe conditions under which a color additive may be
used in this state whether or not those conditions are in accordance
with regulations adopted pursuant to the federal act.

110095.  All special dietary use regulations and any amendments to
regulations adopted pursuant to the federal act, in effect on
November 23, 1970, or adopted on or after that date, are the special
dietary use regulations of this state. If the department finds that
it is necessary to inform purchasers of the value of a food for
special dietary use, it may adopt any special dietary use regulation,
whether or not the regulation is in accordance with the regulations
adopted pursuant to the federal act.

110100.  (a) All food labeling regulations and any amendments to
those regulations adopted pursuant to the federal act, in effect on
January 1, 1993, or adopted on or after that date shall be the food
labeling regulations of this state.
   (b) The department may, by regulation, adopt additional food
labeling regulations. Prior to the adoption of any food labeling
regulation pursuant to this subdivision, the department shall seek
comments from consumer groups and representatives of the food
industry that have been identified by the department as being
affected by the proposed regulation.

110105.  All good manufacturing practices regulations for any food,
drug, device, or cosmetic and any amendments to the regulations
adopted pursuant to the federal act in effect on November 23, 1970,
or adopted on or after such date, are the good manufacturing
practices regulations of this state. If the department finds that it
is necessary for the protection of consumers, it may adopt
interpretative regulations as necessary to define "current good
manufacturing practice" as used in this part.

110110.  (a) All regulations relating to (1) new drug applications,
except for abbreviated new drug applications, adopted pursuant to
Section 505 of the federal act (21 U.S.C. Sec. 355), (2) applications
for premarket approval of new devices, adopted pursuant to Section
515 of the federal act (21 U.S.C. Sec. 360e), (3) postmarketing
reports, recordkeeping, and other postapproval requirements for
approved new drug applications or approved new device premarket
approval applications, adopted pursuant to the federal act, that are
in effect on January 1, 1993, or that are adopted on or after that
date, shall be the new drug and new device application regulations of
this state.
   (b) The department may, by regulation, adopt any new drug or new
device application regulation that it determines is necessary for the
administration and enforcement of this part, whether or not the
regulation is in accordance with the regulations adopted pursuant to
the federal act.

110111.  All nonprescription drug regulations and any amendments to
those regulations adopted pursuant to the federal act, that are in
effect on January 1, 2000, or that are adopted on or after that date,
shall be the nonprescription drug regulations of the state. The
department may adopt any nonprescription drug regulation it deems
necessary for the administration and enforcement of this part,
provided that the regulation is not different from, or in addition
to, any requirement for nonprescription drugs pursuant to Section 751
(21 U.S.C. Sec. 379r) of the federal act.

110115.  A federal regulation adopted pursuant to this part takes
effect in this state 30 days after it becomes effective as a federal
regulation. Any person who will be adversely affected by adoption of
the federal regulation in this state may, within the 30 days prior to
its becoming effective in this state, file with the department, in
writing, objections and a request for a hearing. The timely filing of
substantial objections to a regulation that has become effective
under the federal act, stays the adoption of the regulation in this
state.

110120.  If no substantial objections are received and no hearing is
requested within 30 days after publication of a newly proposed state
regulation, it shall take effect on the date set by the department.
The effective date shall be at least 60 days after the time for
filing objections has expired.

110125.  If substantial objections are made to a federal regulation
within 30 days prior to its becoming effective in this state or to a
proposed regulation within 30 days after it is published, the
department, after notice, shall conduct a public hearing to receive
evidence on issues raised by the objections. Any interested person or
his or her representative may be heard. The department shall act
upon objections by order and shall mail the order to objectors by
certified mail as soon after the hearing as practicable. The order
shall be based on evidence contained in the record of the hearing. If
the order concerns a federal regulation, the department may adopt,
rescind, or modify it. If the order concerns a proposed regulation,
the department may withdraw it or set an effective date for the
regulation as published or as modified by the order. The effective
date shall be at least 60 days after publication of the order.

110130.  Hearings authorized or required by this part shall be
conducted by the department or agent as the department may designate
for that purpose.

110135.  Before any alleged violation of this part is reported to
the Attorney General, a district attorney, or a city attorney for the
institution of a criminal proceeding, the person against whom this
proceeding is contemplated may be given appropriate notice and an
opportunity to show cause why he or she should not be prosecuted and
to present additional facts that may mitigate the action. The showing
may be presented either orally or in writing, in person, or by
attorney.