Article 5. Haccp Exemptions of California Health And Safety Code >> Division 104. >> Part 7. >> Chapter 13. >> Article 5.
(a) Food facilities may engage in any of the following
activities only pursuant to an HACCP plan as specified in Section
114419.1:
(1) Smoking food as a method of food preservation rather than as a
method of flavor enhancement.
(2) Curing food.
(3) Using food additives or adding components such as vinegar as a
method of food preservation rather than as a method of flavor
enhancement, or to render a food so that it is not potentially
hazardous.
(4) Operating a molluscan shellfish life support system display
tank used to store and display shellfish that are offered for human
consumption.
(5) Custom processing animals that are for personal use as food
and not for sale or service in a food facility.
(6) Preparing food by another method that is determined by the
enforcement agency to require an HACCP plan.
(b) Food facilities may engage in the following only pursuant to
an HACCP plan that has been approved by the department:
(1) Using acidification or water activity to prevent the growth of
Clostridium botulinum.
(2) Packaging potentially hazardous food using a reduced-oxygen
packaging method as specified in Section 114057.1.
For a food facility that is required under Section 114419
to have an HACCP plan, the plan and specifications shall indicate
all of the following:
(a) A flow diagram of the specific food for which the HACCP plan
is requested, identifying critical control points and providing
information on the following:
(1) Ingredients, materials, and equipment used in the preparation
of that food.
(2) Formulations or recipes that delineate methods and procedural
control measures that address the food safety concerns involved.
(b) A food employee and supervisory training plan that addresses
the food safety issues of concern.
(c) A statement of standard operating procedures for the plan
under consideration including clearly identifying the following:
(1) Each critical control point.
(2) The critical limits for each critical control point.
(3) The method and frequency for monitoring and controlling each
critical control point by the food employee designated by the person
in charge.
(4) The method and frequency for the person in charge to routinely
verify that the food employee is following standard operating
procedures and monitoring critical control points.
(5) Action to be taken by the person in charge if the critical
limits for each critical control point are not met.
(6) Records to be maintained by the person in charge to
demonstrate that the HACCP plan is properly operated and managed.
(d) Additional scientific data or other information, as required
by the department, supporting the determination that food safety is
not compromised by the proposal.
(a) Applicable HACCP training shall be provided and
documented for food employees who work in the preparation of food for
which an HACCP plan has been implemented. Training given to food
employees shall be documented as to date, trainer, and subject.
(b) Verification of critical limits specified in an HACCP plan
shall be conducted by a laboratory approved by the department prior
to implementation of the HACCP plan. Documentation of laboratory
verification shall be maintained with the HACCP plan for the duration
of its implementation.
(c) No verification of the effectiveness of a critical limit shall
be required if the critical limits used in the HACCP plan do not
differ from the critical limits set forth in this part.
(d) The person operating a food facility pursuant to a HACCP plan
shall designate at least one person to be responsible for
verification of the HACCP plan. Training for the designated person
shall include the seven principles of HACCP and the contents of the
HACCP plan as described in Section 114419.1. HACCP training records
of the designated person shall be retained for the duration of
employment, or a period of not less than two years, whichever is
greater.
(e) Critical limit monitoring equipment shall be suitable for its
intended purpose and shall be calibrated as specified by its
manufacturer. The food facility shall maintain all calibration
records for a period not less than two years.
(a) Except as specified in Section 114419, nothing in
this section shall be deemed to require the enforcement agency to
review or approve an HACCP plan.
(b) The enforcement agency shall collect fees sufficient only to
cover the costs for review, inspections, and any laboratory samples
taken.
(c) An HACCP plan may be disapproved if it does not comply with
HACCP principles.
(d) The enforcement agency may suspend or revoke its approval of
an HACCP plan without prior notice if the agency finds any of the
following:
(1) The plan poses a public health risk due to changes in
scientific knowledge or the hazards present.
(2) The food facility does not have the ability to follow its
HACCP plan.
(3) The food facility does not consistently follow its HACCP plan.
(e) Within 30 days of written notice of suspension or revocation
of approval, the food facility may request a hearing to present
information as to why the HACCP plan suspension or revocation should
not have taken place or to submit HACCP plan changes.
(f) The hearing shall be held within 15 working days of the
receipt of a request for a hearing. Upon written request of the
permitholder, the hearing officer may postpone any hearing date, if
circumstances warrant that action.
(g) The hearing officer shall issue a written notice of decision
within five working days following the hearing. If the decision is to
suspend or revoke approval, the reason for suspension or revocation
shall be included in the written decision.
(a) Each food facility that identifies a trade secret shall
provide in writing to the enforcement agency the information they
consider to be a trade secret.
(b) The enforcement agency shall treat as confidential, to the
extent allowed by law, information that meets the criteria specified
in law for a trade secret and is contained on inspection report forms
and in the plans and specifications submitted as specified under
Section 114419.1.
A microbial challenge study may be submitted to the
enforcement agency for review for purposes of verifying that a food
does not constitute a potentially hazardous food.