114417-114417.7

HEALTH AND SAFETY CODE
SECTION 114417-114417.7




114417.  The department may issue a variance for only the provisions
set forth in Section 113936, if in the opinion of the department,
the alternative practice or procedure is equivalent to the respective
requirements of this part and the alternative practice or procedure
does not result in a health hazard.


114417.1.  (a) Within 180 days after the effective date of this
part, the department shall develop the form of application that an
applicant for a variance must submit. The department may amend the
form as it deems appropriate. The application shall contain, at a
minimum, the following information:
   (1) A detailed description of the requested variance, including
citation to the relevant subdivisions specified in Section 113936.
   (2) An analysis of the science-based rationale upon which the
proposed alternate practice or procedure is based, to include, if and
as appropriate, microbial challenge and process validation studies
demonstrating how potential health hazards dealt with in those
subdivisions that are relevant to the requested variance will be
addressed.
   (3) A description of the specific procedures, processes,
monitoring steps, and other relevant protocols that will be
implemented pursuant to the variance to address potential health
hazards dealt with in those subdivisions specified in Section 113936
that are relevant to the requested variance.
   (4) An HACCP plan, if required pursuant to Section 114419, that
includes all applicable information relevant to the requested
variance.
   (b) An application for a variance shall be submitted to the
department, and must be accompanied at the time of submission by the
fees specified in subdivision (c).
   (c) Each application for a variance shall be accompanied at the
time of submission by payment of fees sufficient to pay the necessary
costs of the department as specified in Section 113717. Any
overpayment by the applicant in excess of the recovery rate and other
costs incurred shall be repaid to the applicant within 30 calendar
days after final action is taken by the department on the
application.



114417.2.  (a) Upon receipt of an application for a variance, the
department shall determine whether the application is substantially
complete and in compliance with Section 114417.1. Within 45 calendar
days after submission of a complete application that complies with
Section 114417.1, the department shall determine whether the
alternate practice or procedure described in the application is
satisfactory and at least the equivalent of the requirements of this
part relating to preventing a health hazard.
   (b) In the event that the department grants the variance, it shall
issue to the applicant a variance letter that shall include, but not
be limited to, the information specified in Section 114417.3.
   (c) The department shall transmit a copy of its variance letter to
all local enforcement agencies.



114417.3.  Each variance letter shall include, have attached to it,
or reference each of the following:
   (a) The information specified in Section 114417.1. That
information may be presented verbatim, in summary form, or by means
of attachment.
   (b) Detailed findings by the department as to the nature and
extent of the potential hazards, if any, that might be implicated
with respect to the requirements specified in this part, and the
manner in which the alternate practice or procedure specified in the
variance will address those hazards.
   (c) The specifics of any operating restrictions or requirements
upon which the granting of the variance is conditioned.
   (d) If appropriate, the particular events, locations, and
operations for which the variance is granted.



114417.4.  A variance letter shall be valid solely with respect to
those food facilities, events, locations, and operations expressly
set forth and only on the specific terms and conditions upon which
the variance is granted. A variance granted by the department shall
be binding on every local enforcement agency.



114417.5.  The permitholder shall retain a copy of the variance
letter on file at the food facility at all times and shall make it
available for inspection by the enforcement officer.



114417.6.  If the department grants a variance, or if an HACCP plan
is required pursuant to Section 114419, the permitholder shall do
both of the following:
   (a) Comply with the HACCP plan and procedures that are submitted
as specified in Sections 114419.1 and 114419.2 and approved as a
condition for the granting of the variance.
   (b) Maintain and provide to the enforcement agency, upon request,
records specified under a HACCP plan, or otherwise pursuant to the
variance letter, that demonstrate that the following are routinely
employed:
   (1) Procedures for monitoring critical control points.
   (2) Monitoring of the critical control points.
   (3) Verification of the effectiveness of an operation or process.
   (4) Necessary corrective actions if there is a failure at a
critical control point.



114417.7.  (a) The department may suspend or revoke a variance if
either of the following occurs:
   (1) The department determines that the variance poses a hazard due
to changes in scientific knowledge or the nature and extent of any
hazard that might result.
   (2) There is a finding that the food facility is not complying
with specific terms and conditions pursuant to which the variance was
granted.
   (b) The department may suspend or revoke a variance upon the
grounds specified in this section only after giving the permitholder
written notice of the proposed suspension or revocation, which shall
include the specific reasons why the variance is proposed to be
suspended or revoked. The permitholder shall be given an opportunity
to be heard, in person, in writing, or through a representative, at
least 24 hours before the variance can be suspended or revoked.