(A) Every frozen dessert manufacturer
shall conduct, or have conducted for it, an analysis to determine whether there
are food safety hazards that are reasonably likely to occur in conjunction with
the manufacturing of frozen dessert and to identify the critical control points
and preventive measures that apply to control those hazards. The analysis shall
include food safety hazards which can occur both within and outside the
processing plant environment, including food safety hazards that can occur
before, during, and after processing. The frozen dessert manufacturers shall
submit their analysis to the director.
(B) If the analysis done under paragraph
(A) of this rule discloses that no food safety hazards are reasonably likely to
occur, the frozen dessert manufacturer shall comply with rules 901:11-2-19 to
901:11-2-22, 901:11-2-25, 901:11-2-27 to 901:11-2-29, 901:11-2-33, 901:11-2-39,
901:11-2-40, 901:11-2-43 to 901:11-2-44 and 901:11-3-01 to 901:11-3-05 of the
Administrative Code and shall be inspected at least once in a twelve month
period by the director.
(C) If the analysis completed under
paragraph (A) of this rule discloses one or more food safety hazards are
reasonably likely to occur the frozen dessert manufacturer shall create and
implement a HACCP plan.
(1) The HACCP plan shall
be specific to:
(a) Each location where frozen desserts are manufactured;
and,
(b) Each kind of frozen dessert manufactured by the
processor.
(2) The HACCP plan shall
be dated and signed:
(a) List the food safety hazards that are reasonably likely to
occur, as identified in accordance with paragraph (A) of this rule, and that
thus must be controlled for each frozen dessert. Consideration should be given
to whether any food safety hazards are reasonably likely to occur as a result
of the following:
(i) Natural
toxins;
(ii) Microbiological
contamination;
(iii) Chemical
contamination;
(iv) Pesticides;
(v) Drug
residues;
(vi) Unapproved use of
direct or indirect food or color additives; and,
(vii) Physical
hazards.
(b) List the critical control points for each of the identified
food safety hazards, including as appropriate:
(i) Critical control
points designed to control food safety hazards that could be introduced in the
processing plant environment; and,
(ii) Critical control
points designed to control food safety hazards introduced outside the
processing plant environment, including food safety hazards that occur before,
during, and after processing.
(c) List the critical limits that must be met at each of the
critical control points;
(d) List the procedures, and frequency thereof, that will be used
to monitor each of the critical control points to ensure compliance with the
critical limits;
(e) Include any corrective action plans that have been developed
in accordance with paragraph (B) of rule 901:11-3-07 of the Administrative
Code;
(f) List the verification procedures, and frequency thereof, that
the processor will use in accordance with paragraph (A) of rule 901:11-3-08 of
the Administrative Code;
(g) Provide for a record keeping system that documents the
monitoring of the critical control points. The records shall contain the actual
values and observations obtained during monitoring.
(D) Signing and dating the HACCP
plan.
(1) The HACCP plan shall
be signed and dated, either by the most responsible individual on-site at the
frozen dessert processing facility or by a higher level official of the
processor. This signature shall signify that the HACCP plan has been accepted
for implementation by the firm.
(2) The HACCP plan shall
be dated and signed:
(a) Upon initial acceptance;
(b) Upon any modification; and,
(c) Upon verification of the plan in accordance with paragraph
(A)(1) of rule 901:11-3-08 of the Administrative Code.
(E) Every frozen dessert manufacturer
required to create and implement a HACCP plan shall submit a copy of their
HACCP plan to the director no later than three months after
licensing.
(F) The director shall, within thirty days of receipt of the
HACCP plan, either approve or disapprove the HACCP plan. The director shall
disapprove the HACCP plan if it does not comply with the requirements of
paragraphs (C) and (D) of this rule.
(G) If the director disapproves a HACCP plan he shall return the
plan to the licensee with a statement of the changes necessary to bring the
plan into compliance. The licensee shall have thirty days from its receipt of
the plan to resubmit it to the director for reconsideration.
(H) The HACCP plan shall be implemented by the frozen dessert
manufacturer within three months of notice of approval of the plan by the
director. Prior to implementation of a HACCP plan, a frozen dessert
manufacturer shall be inspected by the director and comply with the
requirements listed in paragraph (B) of this rule.
(I) A licensed frozen dessert manufacturer shall be exempt from
the requirements of this rule if he requests an exemption in writing and meets
the criteria established in paragraphs (I)(1)(a) to (I)(1)(e) and (I)(2) of
this rule.
(1) The frozen dessert
manufacturer only manufactures frozen dessert mix for sale and no other frozen
dessert and all of the following apply;
(a) The frozen dessert manufacturer holds a processor license
with a category designation of grade A fluid milk processor, grade A cultured
milk processor or grade A condensed milk products processor;
(b) The equipment and facility used to manufacture frozen dessert
mix is routinely inspected by the director and used in the processing of grade
"A" dairy products;
(c) The temperature requirements for pasteurization in rule
901:11-3-05 of the Administrative Code are met;
(d) The frozen dessert manufacturer maintains the frozen dessert
mix in compliance with the requirements of rule 901:11-3-04 of the
Administrative Code; and,
(e) The frozen dessert is manufactured in compliance with rules
901:11-3-01 to 901:11-3-05 of the Administrative Code.
(2) The frozen dessert
manufacturer produces ten thousand gallons or less of frozen dessert
annually.
(J) A frozen dessert manufacturer that meets the requirements of
paragraphs (I)(1)(a) to (I)(1)(e) and (I) (2) of this rule shall be inspected
at least once in a twelve month period by the director and shall comply with
the requirements listed in paragraph (B) of this rule.