[Comment: For publication dates of the C.F.R. referenced in
this rule, see paragraph (B)(15)(b) of rule
3717-1-01 of the Administrative
Code.]
(A) Frozen food - temperature
and time control.
Stored frozen foods are to be maintained frozen.
(B) Time/temperature controlled
for safety food - slacking.
Frozen time/temperature controlled for safety food that is
slacked to moderate the temperature is to be held:
(1) Under refrigeration that maintains the
food temperature at forty-one degrees Fahrenheit (five degrees Celsius) or
less; or
(2) At any temperature if
the food remains frozen.
(C) Thawing - temperature and time control.
Except as specified in paragraph (C)(4) of this rule,
time/temperature controlled for safety food is to be thawed:
(1) Under refrigeration that maintains the
food temperature at forty-one degrees Fahrenheit (five degrees Celsius) or
less; or
(2) Completely submerged
under running water:
(a) At a water
temperature of seventy degrees Fahrenheit (twenty-one degrees Celsius) or
below;
(b) With sufficient water
velocity to agitate and float off loose particles in an overflow; and
(c) For a period of time that does not allow
thawed portions of ready-to-eat food to rise above forty-one degrees Fahrenheit
(five degrees Celsius); or
(d) For
a period of time that does not allow thawed portions of a raw animal food
subject to cooking requirements specified under paragraph (A)(1) or (A)(4) of
rule
3717-1-03.3 of the
Administrative Code to be above forty- one degrees Fahrenheit (five degrees
Celsius), for more than four hours including:
(i) The time the food is exposed to the
running water and the time needed for preparation for cooking; or
(ii) The time it takes under refrigeration to
lower the food temperature to forty-one degrees Fahrenheit (five degrees
Celsius).
(3)
As part of a cooking process if the food that is frozen is:
(a) Cooked as specified under paragraph
(A)(1) or (A)(4) of rule
3717-1-03.3 of the
Administrative Code
,
or paragraph (B) of rule
3717-1-03.3
of the Administrative Code, or paragraph (E) of rule
3717-1-03.3 of the
Administrative Code; or
(b) Thawed
in a microwave oven and immediately transferred to conventional cooking
equipment, with no interruption in the process; or
(4) Using any procedure if a portion of
frozen ready-to-eat food is thawed and prepared for immediate service in
response to an individual consumer's order.
(5) Reduced oxygen packaged fish that bears a
label indicating that it is to be kept frozen until time of use is to be
removed from the reduced oxygen environment:
(a) Prior to its thawing under refrigeration
as specified in paragraph (C)(1) of this rule; or
(b) Prior to, or immediately upon completion
of its thawing, using procedures specified in paragraph (C)(2) of this
rule.
(D)
Cooling - temperature and time control.
(1)
Cooked time/temperature controlled for safety food is to be cooled:
(a) Within two hours from one hundred
thirty-five degrees Fahrenheit (fifty- seven degrees Celsius) to seventy
degrees Fahrenheit (twenty-one degrees Celsius); and
(b) Within a total of six hours from one
hundred thirty-five degrees Fahrenheit (fifty-seven degrees Celsius) to
forty-one degrees Fahrenheit (five degrees Celsius) or less.
(2) Time/temperature controlled
for safety food is to be cooled within four hours to forty-one degrees
Fahrenheit (five degrees Celsius) or less if prepared from ingredients at
ambient temperature, such as reconstituted foods and canned tuna.
(3) Except as specified under paragraph
(D)(4) of this rule, a time/temperature controlled for safety food received in
compliance with laws allowing a temperature above forty-one degrees Fahrenheit
(five degrees Celsius) during shipment from the supplier as specified in
paragraph (H)(1) of rule
3717-1-03.1 of the
Administrative Code, is to be cooled within four hours to forty-one degrees
Fahrenheit (five degrees Celsius) or less.
(4) Raw eggs are to be received as specified
under paragraph (H)(1) of rule
3717-1-03.1 of the
Administrative Code and immediately placed in refrigerated equipment that
maintains an ambient air temperature of forty-five degrees Fahrenheit (seven
degrees Celsius) or less.
(E) Cooling methods - temperature and time
control.
(1) Cooling is to be accomplished in
accordance with the time and temperature criteria specified under paragraph (D)
of this rule by using one or more of the following methods based on the type of
food being cooled:
(a) Placing the food in
shallow pans;
(b) Separating the
food into smaller or thinner portions;
(c) Using rapid cooling equipment;
(d) Stirring the food in a container placed
in an ice water bath;
(e) Using
containers that facilitate heat transfer;
(f) Adding ice as an ingredient; or
(g) Other effective methods.
(2) When placed in cooling or cold
holding equipment, food containers in which food is being cooled are to be:
(a) Arranged in the equipment to provide
maximum heat transfer through the container walls; and
(b) Loosely covered, or uncovered if
protected from overhead contamination as specified under paragraph (Q)(2) of
rule
3717-1-03.2 of the
Administrative Code, during the cooling period to facilitate heat transfer from
the surface of the food.
(F) Time/temperature controlled for safety
food - hot and cold holding.
(1) Except during
preparation, cooking, or cooling, or when time is used as the public health
control as specified under paragraph (I) of this rule, and except as specified
under paragraph (F)(2) and in paragraph (F)(3) of this rule, time/temperature
controlled for safety food is to be maintained at a temperature specified as
follows:
(a) At one hundred thirty-five
degrees Fahrenheit (fifty-seven degrees Celsius) or above, except that roasts
cooked to a temperature and for a time specified in paragraph (A)(4) of rule
3717-1-03.3 of the
Administrative Code or reheated as specified in paragraph (
H
I)(1) of rule
3717-1-03.3 of the
Administrative Code may be held at a temperature of one hundred thirty degrees
Fahrenheit (fifty-four degrees Celsius) or above; or
(b) At forty-one degrees Fahrenheit (five
degrees Celsius) or less.
(2) Eggs that have not been treated to
destroy all viable Salmonellae are to be stored in refrigerated equipment that
maintains an ambient air temperature of forty- five degrees Fahrenheit (seven
degrees Celsius) or less.
(3)
Time/temperature controlled for safety food in a homogenous liquid form may be
maintained outside of the temperature control requirements, as specified under
paragraph (F)(1) of this rule, while contained within specially designed
equipment that complies with the design and construction requirements as
specified under paragraph (Q)(5) of rule
3717-1-04.1 of the
Administrative Code.
(G)
Ready-to-eat, time/temperature controlled for safety food - date marking.
(1) Except when packaging food using a
reduced oxygen packaging method as specified under paragraph (K) of this rule,
and except as specified in paragraphs (G)(5) and (G)(6) of this rule,
refrigerated, ready-to-eat, time/temperature controlled for safety food
prepared and held in a food service operation or in a retail food establishment
for more than twenty-four hours is to be clearly marked to indicate the date or
day by which the food is to be consumed on the premises, sold, or discarded
when held at a temperature of forty-one degrees Fahrenheit (five degrees
Celsius) or less for a maximum of seven days. The day of preparation is counted
as day one.
(2) Except as specified
in paragraphs (G)(5) to (G)(7) of this rule; refrigerated, ready- to-eat
time/temperature controlled for safety food prepared and packaged by a food
processing plant is to be clearly marked, at the time the original container is
opened in a food service operation or retail food establishment and if the food
is held for more than twenty-four hours, to indicate the date or day by which
the food is to be consumed on the premises, sold, or discarded, based on the
temperature and time combination specified in paragraph (G)(1) of this rule
and:
(a) The day the original container is
opened in the food service operation or retail food establishment is counted as
day one; and
(b) The day or date
marked by the food service operation or retail food establishment cannot exceed
a manufacturer's use-by date if the manufacturer determined the use-by date
based on food safety.
(3)
A refrigerated, ready-to-eat, time/temperature controlled for safety food
ingredient or a portion of a refrigerated, ready-to-eat, time/temperature
controlled for safety food that is subsequently combined with additional
ingredients or portions of food is to retain the date marking of the earliest-
prepared or first-prepared ingredient.
(4) A date marking system that meets the
criteria stated in paragraphs (G)(1) and (G)(2) of this rule may include:
(a) Using a method approved by the licensor
for refrigerated, ready-to-eat time/temperature controlled for safety food that
is frequently rewrapped, such as lunch meat or a roast, or for which date
marking is impractical, such as soft serve mix or milk in a dispensing
machine;
(b) Marking the date or
day of preparation, with a procedure to discard the food on or before the last
date or day by which the food is to be consumed on the premises, sold, or
discarded as specified under paragraph (G)(1) of this rule;
(c) Marking the date or day the original
container is opened in a food service operation or retail food establishment,
with a procedure to discard the food on or before the last date or day by which
the food is to be consumed on the premises, sold, or discarded as specified
under paragraph (G)(2) of this rule; or
(d) Using calendar dates, days of the week,
color-coded marks, or other effective marking methods, provided that the
marking system is disclosed to the licensor upon request.
(5) Paragraphs (G)(1) and (G)(2) of this rule
do not apply to individual meal portions served or repackaged for sale from a
bulk container upon a consumer's request.
(6) Paragraphs (G)(1) and (G)(2) of this rule
do not apply to shellstock.
(7)
Paragraph (G)(2) of this rule does not apply to the following foods prepared
and packaged by a food processing plant under inspection:
(a) Deli salads manufactured in accordance
with
21 C.F.R. 110
117, such as ham salad, seafood salad, chicken salad,
egg salad, pasta salad, potato salad, and macaroni salad;
(b) Hard cheeses containing not more than
thirty-nine per cent moisture as defined in 21 C.F.R.
133, such as cheddar,
gruyere, parmesan and reggiano, and romano;
(c) Semi-soft cheeses containing more than
thirty-nine per cent moisture, but not more than fifty per cent moisture, as
defined in 21 C.F.R.
133, such as blue, edam, gorgonzola, gouda, and monterey
jack;
(d) Cultured dairy products
as defined in 21 C.F.R.
131, such as yogurt, sour cream, and
buttermilk;
(e) Preserved fish
products, such as pickled herring and dried or salted cod, and other acidified
fish products defined in 21 C.F.R.
114;
(f) Shelf stable, dry fermented sausages,
such as pepperoni and Genoa; and
(g) Shelf stable salt-cured products such as
prosciutto and Parma (ham).
(H) Ready-to-eat, time/temperature controlled
for safety food - disposition.
(1) A food
specified under paragraph (G)(1) or (G)(2) of this rule is to be discarded if
it:
(a) Exceeds the temperature or time
specified in paragraph (G)(1) of this rule, except time that the product is
frozen;
(b) Is in a container or
package that does not bear a date or day; or
(c) Is in
appropriately marked with a date or day that exceeds the temperature and time
combination as specified in paragraph (G)(1) of this rule.
(2) Refrigerated, ready-to-eat,
time/temperature controlled for safety food, dispensed through a vending
machine with an automatic shut-off control, is to be discarded if the automatic
shut-off control is activated as specified in paragraph (Y)(2) of rule
3717-1-04.1 of the
Administrative Code.
(3)
Refrigerated, ready-to-eat, time/temperature controlled for safety food,
displayed at a micro market, is to be discarded if the automatic shutoff
control is activated as specified in paragraph (MM)(1) of rule
3717-1-04.1 of the
Administrative Code.
(I)
Time as a public health control.
(1) If time
without temperature control is used as the public health control for a working
supply of time/temperature controlled for safety food before cooking, or for
ready-to-eat time/temperature controlled for safety food that is displayed or
held for sale or service, written procedures are to be prepared in advance,
maintained in the food service operation or retail food establishment and made
available to the licensor upon request that specify:
(a) Methods of compliance with paragraphs
(I)(2)(a) to (I)(2)(e), or paragraphs (I)(3)(a) to (I)(3)(e) of this rule;
and
(b) Methods of compliance with
paragraph (D) of this rule for food that is prepared, cooked, and refrigerated
before time is used as a public health control.
(2) If time without temperature control is
used as the public health control up to a maximum of four hours:
(a) The food is to have an initial
temperature of forty-one degrees Fahrenheit (five degrees Celsius) or less when
removed from cold holding temperature control, or one hundred thirty-five
degrees Fahrenheit (fifty- seven degrees Celsius) or greater when removed from
hot holding temperature control;
(b)
The food may have
an initial temperature of seventy degrees Fahrenheit (twenty-one degrees
Celsius) or less if;
(i)
It is a ready-to-eat fruit or vegetable that upon
cutting is rendered a time/temperature controlled for safety food as defined in
paragraph (B)(125) of rule
3717-1-01 of the Administrative
Code; or
(ii)
It is a ready-to-eat hermetically sealed food that upon
opening is rendered a time/temperature controlled for safety food as defined in
paragraph (B)(125) of rule
3717-1-01 of the Administrative
Code;
(iii)
It is a non-time/tempeature controlled for safety
batter mix that contains dried milk and/or eggs and becomes a time/temperature
controlled for safety food upon mixing with water such as waffle, pancake, or
muffin batter mixes;
(iv)
The food temperature does not exceed seventy degrees
Fahrenheit (twenty-one degrees Celsius) within a maximum time period of four
hours from the time it was rendered a time/temperature controlled for safety
food; and
(v)
The food is marked or otherwise identified to indicate
the time that is four hours past the point in time when the food is rendered a
time/temperature controlled for safety food as specified in (I)(2)(b)(i) and
(I)(2)(b)(ii) of this rule.
(b)(c) The food is to be
marked or otherwise identified to indicate the time that is four hours past the
point in time when the food is removed from temperature control;
(c)(d)
The food is to be cooked and served, served at any temperature if ready-
to-eat, or discarded, within four hours from the point in time when the food is
removed from temperature control; and
(d)(e) The food in
unmarked containers or packages, or marked to exceed a four-hour limit will be
discarded.
(3) If time
without temperature control is used as the public health control up to a
maximum of six hours:
(a) The food is to have
an initial temperature of forty-one degrees Fahrenheit (five degrees Celsius)
or less when removed from temperature control and the food temperature cannot
exceed seventy degrees Fahrenheit (twenty- one degrees Celsius) within a
maximum time period of six hours;
(b) The food is to be monitored to ensure the
warmest portion of the food does not exceed seventy degrees Fahrenheit
(twenty-one degrees Celsius) during the six-hour period, unless an ambient air
temperature is maintained that ensures the food does not exceed seventy degrees
Fahrenheit (twenty-one degrees Celsius) during the six-hour holding
period;
(c) The food is to be
marked or otherwise identified to indicate:
(i) The time when the food is removed from
forty-one degrees Fahrenheit (five degrees Celsius) or less cold holding
temperature control; and
(ii) The
time that is six hours past the point in time when the food is removed from
cold holding temperature control.
(d) The food is to be:
(i) Discarded if the temperature of the food
exceeds seventy degrees Fahrenheit (twenty-one degrees Celsius); or
(ii) Cooked and served, served at any
temperature if ready-to-eat, or discarded within a maximum of six hours from
the point in time when the food is removed from forty-one degrees Fahrenheit
(five degrees Celsius) or less cold holding temperature control; and
(e) The food in unmarked
containers or packages, or marked with a time that exceeds the six-hour limit
will be discarded.
(4) A
food service operation or a retail food establishment that serves a highly
susceptible population, is not permitted to
use time as specified under paragraph (I)(1), (I)(2) or (I)(3) of this rule as
the public health control for raw eggs that are for service to a highly
susceptible population.
(J) Variance requirement.
The license holder is obligated to obtain a variance from the
Ohio department of health if an operation is a food service operation, or from
the Ohio department of agriculture if an operation is a retail food
establishment before:
(1) Smoking food
as a method of food preservation rather than as a method of flavor
enhancement;
(2) Curing
food;
(3) Except as
provided
specified in rule
3717-1-08.4 of the
Administrative Code, 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 a time/temperature controlled for safety
food;
(4) Packaging
time/temperature controlled for safety food using a reduced oxygen packaging
method except where the growth of and toxin formation by Clostridium botulinum
and the growth of Listeria monocytogenes are controlled as specified under
paragraph (K) of this rule;
(5)
Operating a molluscan shellfish life-support system display tank used to store
or display shellfish that are offered for human consumption;
(6) Custom processing of animals that are for
personal use as food and not for sale or service in a food service operation or
retail food establishment if the processing is not done in compliance with rule
3717-1-08.2 of the
Administrative Code;
(7) Pressing
or bottling juice unless the processing is done in compliance with rule
3717-1-08 of the Administrative
Code;
(8) Use of a heat treatment
dispensing freezer in a manner other than as specified in rule
3717-1-08.1 of the
Administrative Code;
(9) Preparing
food by another method that is determined by the Ohio department of health or
Ohio department of agriculture to warrant a variance; or
(10) Sprouting seeds or beans.
(K) Reduced oxygen packaging
without a variance, criteria.
(1) Except for a
food service operation or retail food establishment that obtains a variance as
specified under paragraph (J) of this rule, a food service operation or retail
food establishment that packages time/temperature controlled for safety food
using a reduced oxygen packaging method is obligated to control the growth and
toxin formation of Clostridium botulinum and the growth of Listeria
monocytogenes.
(2) Except as
specified under paragraph (K)(7) of this rule
, a
food service operation or retail food establishment that packages
time/temperature controlled for safety food using a reduced oxygen packaging
method
shall
is
obligated to have a HACCP plan that contains the information specified
under paragraph (L) of this rule and that:
(a)
Identifies the food to be packaged;
(b) Except as specified under paragraphs
(K)(3) to (K)(7) of this rule, ensures the packaged food is to be maintained at
forty-one degrees Fahrenheit (five degrees Celsius) or less and meet at least
one of the following criteria:
(i) Has an aw
of 0.91 or less;
(ii) Has a pH of
4.6 or less;
(iii) Is a meat or
poultry product cured at a food processing plant regulated by the Ohio
department of agriculture under Chapter 918. of the Revised Code or USDA using
substances specified in 9
C.F.R.
424.21, and is received in an intact
package; or
(iv) Is a food with a
high level of competing organisms such as raw meat, raw poultry, or raw
vegetables.
(c) Describes
how the package will be prominently and conspicuously labeled on the principal
display panel in bold type on a contrasting background, with instructions to:
(i) Maintain the food at forty-one degrees
Fahrenheit (five degrees Celsius) or below; and
(ii) Discard the food if within thirty
calendar days of its packaging it is not served for on-premises consumption, or
consumed if served or sold for off-premises consumption.
(d) Limits the refrigerated shelf life to no
more than thirty calendar days from packaging to consumption, except the time
the product is maintained frozen, or the original manufacturer's "sell by" or
"use by" date, whichever occurs first;
(e) Includes operational procedures that:
(i) Prevent contacting ready-to-eat food with
bare hands as specified under paragraph (A)(2) of rule
3717-1-03.2 of the
Administrative Code;
(ii) Identify
a designated work area and the method by which:
(a) Physical barriers or methods of
separation of raw foods and ready-to-eat foods minimize cross contamination;
and
(b) Access to the processing
equipment is limited to responsible trained personnel familiar with the
potential hazards of the operation; and
(iii) Delineate cleaning and sanitization
procedures for food-contact surfaces; and
(f) Describes the training program that
ensures that the individual responsible for the reduced oxygen packaging
operation understands the:
(i) Concepts needed
for a safe operation;
(ii)
Equipment and facilities; and
(iii)
Procedures specified under paragraph (K)(2)(e) of this rule and the HACCP plan
for the operation.
(g)
Is provided to the
Regulatory
regulatory
authority is notified prior to
implementation.
(3)
Except for fish that is frozen before, during, and after packaging
and bears a label indicating that it is to be kept
frozen until time of use, a food service operation or retail food
establishment is not permitted to package fish using a reduced oxygen packaging
method.
(4)
A commercially prepared food that is ready-to-eat, received
frozen in an intact package, maintained frozen before, during and after
packaging, and bears a label indicating that it is to be kept frozen until time
of use may be re-packaged using a reduced oxygen packaging
method.
(4)(5) Except as specified
under paragraphs (K)(3), (K)(4), and (K)(7) of this rule, a food service
operation or retail food establishment that packages time/temperature
controlled for safety food using a cook-chill or sous vide process is obligated
to:
(a) Notify the regulatory authority prior
to implementation and execute a HACCP plan that contains the information as
specified under paragraph (L) of this rule;
(b) Ensure the food is:
(i) Prepared and consumed on the premises
with no distribution or sale of the packaged product to another business
location or the consumer;
(ii)
Cooked to heat all parts of the food to a temperature and for a time as
specified under paragraphs (A)(1), (A)(2) and (A)(4) of rule
3717-1-03.3 of the
Administrative Code;
(iii)
Protected from contamination before and after cooking as specified under rule
3717-1-03.2 of the
Administrative Code and under rule
3717-1-03.3 of the
Administrative Code;
(iv) Placed in
a package with an oxygen barrier and sealed before cooking, or placed in a
package and sealed immediately after cooking and before reaching a temperature
below one hundred thirty-five degrees Fahrenheit (fifty-seven degrees
Celsius);
(v) Cooled to forty-one
degrees Fahrenheit (five degrees Celsius) in the sealed package or bag as
specified under paragraph (D) of this rule, and:
(a) Cooled to thirty-four degrees Fahrenheit
(one degree Celsius) within forty-eight hours of reaching forty-one degrees
Fahrenheit (five degrees Celsius) and held at that temperature until consumed
or discarded within thirty days after the date of packaging;
(b) Held at forty-one degrees Fahrenheit
(five degrees Celsius) or less for no more than seven days, at which time the
food is to be consumed or discarded; or
(c)
Cooled to thirty-four degrees Fahrenheit (one degree
Celsius) within forty-eight hours of reaching forty-one degrees Fahrenheit
(five degrees Celsius), removed from refrigeration equipment that maintains a
thirty-four degrees Fahrenheit (one degree Celsius) food temperature and then
held at forty- one degrees Fahrenheit (five degrees Celsius) or less for no
more than seven days, not to exceed thirty days from its date of packaging, at
which time the food is to be consumed or discarded; or
(c)(d)
Held frozen with no shelf life restriction while frozen until consumed or
used.
(vi) Held in a
refrigeration unit that is equipped with an electronic system that continuously
monitors time and temperature and is visually examined for proper operation
twice daily; and
(vii) Labeled with
the product name and the date packaged; and
(c) Maintain the records to confirm that
cooling and cold holding refrigeration time/temperature parameters are
monitored as part of the HACCP plan, and:
(i)
Make such records available to the regulatory authority upon request;
and
(ii) Hold such records for at
least six months; and
(d)
Implement written operational procedures as specified under paragraph (K)(2)(e)
of this rule and a training program as specified under paragraph (K)(2)(f) of
this rule.
(5)(6) Except as specified
under paragraph (K)(7) of this rule, a food service operation or retail food
establishment that packages cheese using a reduced oxygen packaging method is
obligated to:
(a) Limit the cheeses packaged
to those that are commercially manufactured in a food processing plant with no
ingredients added in the food service operation or retail food establishment
and that meet the standards of identity as specified in
21 C.F.R.
133.150,
21 C.F.R.
133.169 or
21 C.F.R.
133.187;
(b) Have a HACCP plan that contains the
information specified under paragraph (L) of this rule and as specified under
paragraphs (K)(2)(a), (K)(2)(c)(i), (K)(2)(e) and (K)(2)(f) of this
rule;
(c) Labels the package on the
principal display panel with a "use by" date that does not exceed thirty days
from its packaging or the original manufacturer's "sell by" or "use by" date,
whichever occurs first; and
(d)
Discards the reduced oxygen packaged cheese if it is not sold for off- premises
consumption or consumed within thirty calendar days of its packaging.
(6)
(7) A HACCP plan is not needed for a specific food
when a food service operation or retail food establishment uses a reduced
oxygen packaging method to package that specific time/temperature controlled
for safety food that is always:
(a) Labeled
with the production time and date;
(b) Held at forty-one degrees Fahrenheit
(five degrees Celsius) or less during refrigerated storage; and
(c) Removed from its package in the food
service operation or retail food establishment within forty-eight hours after
packaging.
(L)
Contents of a HACCP plan.
For a food service operation or retail food establishment that
has a HACCP plan, the plan and specifications is obligated to include:
(1) A flow diagram by specific food or
category type including all steps in the process from
the receiving of ingredients to the final sale or service to the consumer, and
identifying critical control points.
and providing information on the
following:
(a)(2)
Ingredients
List of
ingredients, materials, and equipment used in the preparation of that
food; and
(b)(3) Formulations or
recipes that delineate methods and procedural control measures that address the
food safety concerns involved;
(2)(4) A
detailed, step-by-step written description of the
process;
training
program that ensures individuals responsible for implementing the HACCP plan
understand the:
(a) Application of HACCP
principles;
(b) Procedures identified in the
HACCP plan;
(c) Maintenance of records and
verification of procedures identified in the HACCP plan; and
(d) Maintenance of equipment and
facilities.
(5)
A complete hazard analysis identifying the following
for each step in the flow chart:
(a)
Relevant biological, chemical, and physical
hazards;
(b)
Determination if the identified hazards are
significant;
(c)
Justification of determination whether it is a
significant hazard;
(d)
Control measures that may be applied to prevent the
significant hazards for the step; and
(e)
Determination
whether the step is a critical control point;
(3)(6) A
statement of standard operating procedures for the
plan under consideration including
HACCP plan
summary clearly identifying:
(a) Each
critical control point;
(b) The
critical limits for each critical control point;
(c) The method and frequency for monitoring
and controlling each critical control point by the food employee designated by
the person in charge;
(d) 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;
(e)
Corrective actionAction to be taken by the person in charge if the
critical limits for each critical control point are not met; and
(f) Records to be maintained by the person in
charge to demonstrate that the HACCP plan is properly operated and managed.
(4)(7) Additional
scientific data or other information, as mandated by the regulatory authority,
supporting the determination that food safety is not compromised by the
proposal.
(8)
Sanitary standard operating procedures that identify
the procedures implemented to prevent direct contamination or adulteration of
the products made in the food service operation or retail food establishment,
including but not limited to:
(a)
Identification of procedures to be completed prior to
beginning process;
(b)
Proper cleaning and sanitizing of food contact
surfaces, equipment, and utensils;
(c)
Proper
handwashing procedures and frequency; and
(d)
Identification of
persons who are responsible for implementation of the sanitary standard
operating procedures.
(9)
A description of
the training program that ensures individuals responsible for implementing the
HACCP plan understand the:
(a)
Application of HACCP principles;
(b)
Procedure
identified in the HACCP plan;
(c)
Maintenance of
records and verification of procedures identified in the HACCP plan;
and
(d)
Maintenance of equipment and
facilities.