3717-1-03.4(K) Food: limitation of growth of organisms of public health concern

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 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 authority 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.

(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;

(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

(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.

(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.

(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.