HACCP plans in North Carolina

The North Carolina Food Code, as applied in Wake County, requires a HACCP plan for specialized processes because they raise the risk of severe foodborne illness.

"The North Carolina Food Code requires a Hazard Analysis Critical Control Point (HACCP) plan for conducting specialized processes (listed below), because these processes significantly increase the risk of severe foodborne illness. Specialized Processes that require an approved HACCP plan include:"

Processes Requiring a County-Approved HACCP Plan, undated

The HACCP plan must be approved before the operator starts a specialized process such as vacuum sealing, curing, pickling or cook-chill.

"Your HACCP plan must be approved PRIOR to conducting a specialized process such as vacuum sealing, curing, pickling, cook-chill, etc."

Processes Requiring a County-Approved HACCP Plan, undated

A restaurant chain operating in more than one North Carolina county must get its HACCP plan or variance approved by the state committee rather than by the county.

"If your restaurant chain operates in multiple counties of North Carolina, your HACCP plan or Variance will have to be approved by the State of North Carolina HACCP Committee."

Multi-County HACCP Plans and Variances, undated

The verification procedure must include notifying Wake County Environmental Services of any change to the HACCP plan.

"Must include notification of Wake County Environmental Services if any changes are made to the HACCP plan."

Verification & Record Keeping, undated (file name fillable_HACCP Application_6_20_16; text cites the 2009 NC Food Code)

Variance applications go to Wake County first for initial review before the county forwards them to the state Variance Committee, and must include the Request for Variance and a completed Variance Components Checklist.

"To apply for a variance, you must complete a variance application and submit it to Wake County for initial review prior to submittal to the state Variance Committee. Applications must include a request for Variance and a fully completed Variance Components Checklist."

Processes Requiring a State-issued Variance, undated

Completed variance applications are submitted to the Wake County Environmental Services HACCP Coordinator.

"Submit completed applications to Wake County Environmental Services HACCP Coordinator."

Processes Requiring a State-issued Variance, undated

Any other reduced oxygen packaging needs a state variance with independent validation such as a written secondary barrier, manufacturer certification, approved laboratory analysis, or microbiological studies by a process authority.

"Any Reduced Oxygen Packaging that does not fall under any of these guidelines will require a State Variance with Independent Validation such as:"

State Variance with Independent Validation, undated (file name 20201105_HACCP Quick Guide)

HACCP records must be kept for the stated number of months and kept on site for inspection.

"Records must be held for six months and kept on site for review during inspection."

Verification & Record Keeping, Record Keeping, undated (file name fillable_HACCP Application_6_20_16; text cites the 2009 NC Food Code)

Sous vide cooking that reaches standard final cooking temperatures needs a county-approved HACCP plan.

"Cooking food using the sous-vide method while reaching standard final cooking temperatures."

Processes Requiring a County-Approved HACCP Plan, undated

Sous vide outside standard temperature parameters needs a state-issued variance.

"Cooking food using the sous-vide method outside of standard temperature parameters."

Processes Requiring a State-issued Variance, undated

Sous vide or cook-chill under a county HACCP plan needs continuous cold holding monitoring, consumption within the same business entity, and sealing before cooking or right after cooking before the food cools below the hot holding temperature.

"Sous Vide or Cook Chill Continuous monitoring device for cold holding and Food is prepared and consumed on premises or prepared and consumed off premises, but within the same business entity and Sealed before cooking, or immediately after cooking and before reaching a temperature below 135F and"

County Approved HACCP Plan, Sous Vide or Cook Chill, undated (file name 20201105_HACCP Quick Guide)

Holding sous vide or cook-chill food at standard cold holding temperature for the longer stated period requires a state variance.

"Sous Vide or Cook Chill held for up to 7 days at 41F or below"

State Variance, Referencing 2013 Food Code for Validation, undated (file name 20201105_HACCP Quick Guide)

A circulator is mandatory for sous vide and a data logger is mandatory for cook-chill and sous vide.

"Circulator (mandatory for Sous-Vide) Data Logger (mandatory for Cook Chill/Sous-Vide (3-501.12 (D)(f)))"

Equipment List (REQUIRED), undated (file name fillable_HACCP Application_6_20_16; text cites the 2009 NC Food Code)

Cook-chill preparation and storage needs a county-approved HACCP plan under certain circumstances.

"Preparing and storing food using the cook-chill method under certain circumstances."

Processes Requiring a County-Approved HACCP Plan, undated

Cook-chill storage beyond the stated number of hours needs a state-issued variance.

"Preparing and storing food using the cook-chill method for longer than 72 hours."

Processes Requiring a State-issued Variance, undated

Sous vide or cook-chill food must be cooled in two stages within the stated times.

"Cooled to 70F within two hours and to 41F within six hours and either"

County Approved HACCP Plan, Sous Vide or Cook Chill, undated (file name 20201105_HACCP Quick Guide)

One county storage option for sous vide or cook-chill is further cooling to the lower temperature within the stated time and holding there for no more than the stated days.

"Cooled to 34F within 48 hours of reaching 41F and held at that temperature for no more than 30 days or"

County Approved HACCP Plan, Sous Vide or Cook Chill, undated (file name 20201105_HACCP Quick Guide)

Another county option is cooling to the lower temperature and then holding at the standard cold holding temperature for no more than the stated hours.

"Cooled to 34F with 48 of reaching 41F and then held at 41F or below for no more than 72 hours or"

County Approved HACCP Plan, Sous Vide or Cook Chill, undated (file name 20201105_HACCP Quick Guide)

Another county option is cooling to an intermediate temperature within the stated time and holding there for no longer than the stated hours.

"Cooled to 38F with 24 hours of reaching 41F and held there for no longer than 72 hours or"

County Approved HACCP Plan, Sous Vide or Cook Chill, undated (file name 20201105_HACCP Quick Guide)

Sous vide or cook-chill food held frozen has no shelf life restriction.

"Held frozen with no shelf life restriction"

County Approved HACCP Plan, Sous Vide or Cook Chill, undated (file name 20201105_HACCP Quick Guide)

Sous vide and cook-chill food must be held in refrigeration with an electronic system that continuously monitors time and temperature and is checked visually twice daily.

"Food must be 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"

For SOUS-VIDE and COOK-CHILL only, undated (file name fillable_HACCP Application_6_20_16; text cites the 2009 NC Food Code)

Vacuum packaging raw meats, raw and frozen fish, raw poultry, hard cheeses or raw vegetables needs a county-approved HACCP plan.

"Vacuum packaging raw meats, raw & frozen fish, raw poultry, hard cheeses, or raw vegetables."

Processes Requiring a County-Approved HACCP Plan, undated

Vacuum packaging cooked food needs a variance from the State of North Carolina Variance Committee.

"Examples of Specialized Processes that require a variance from the State of North Carolina Variance Committee include: Vacuum packaging cooked food."

Processes Requiring a State-issued Variance, undated

Under a county-approved HACCP plan, reduced oxygen packaged food may be held cold only for the stated shorter period.

"County Approved HACCP Plan Reduced Oxygen Packaging, held for up to 14 days at 41F or less"

County Approved HACCP Plan, undated (file name 20201105_HACCP Quick Guide)

The county HACCP path for reduced oxygen packaging covers raw meat, poultry or vegetables, or foods with a low pH or low water activity, or meat and poultry cured at a USDA plant.

"Raw meat, poultry, vegetables or Foods with a pH at 4.6 or below or Foods with a water activity level at 0.91 or below or Meats or poultry cured at a USDA regulated processing plant"

County Approved HACCP Plan, undated (file name 20201105_HACCP Quick Guide)

Holding reduced oxygen packaged food for the longer Food Code period requires a state variance validated against the later Food Code edition named in the guide.

"State Variance, Referencing 2013 Food Code for Validation Reduced Oxygen Packaging, held for up to 30 days at 41F or less"

State Variance, Referencing 2013 Food Code for Validation, undated (file name 20201105_HACCP Quick Guide)

Other reduced oxygen, cook-chill and sous vide products kept sealed only briefly, labeled with time and date packaged and kept cold need no HACCP plan or variance under the guide's layout.

"All other ROP, cook chill and sous vide products held sealed for no more than 48 hours Always labeled with time and date packaged and Stored at 41F or below"

Quick Guide, short hold row, undated (file name 20201105_HACCP Quick Guide)

The county HACCP packet limits shelf life for raw meat, poultry or vegetables and for cheeses, requires cold holding at all times, limits cook-chill to a short hold, and requires raw fish to stay frozen.

"Must be 14 days or less for Raw MEAT, POULTRY, or Vegetables/30 days or less for Cheeses and held below 41°F at all times (3-501.12 (B)(4)). For Cook-Chill must be 72 hours or less (3-501.12 (D)(2)(e)(i-iv)). Raw FISH must be kept FROZEN before, during, and after packaging."

Time/Shelf-Life, undated (file name fillable_HACCP Application_6_20_16; text cites the 2009 NC Food Code)

Raw fish may be reduced oxygen packaged under a county HACCP plan only if frozen before, during and after packaging.

"Raw fish that is frozen before, during and after packaging"

County Approved HACCP Plan, undated (file name 20201105_HACCP Quick Guide)

Commercially processed hard, semisoft or pasteurized process cheeses in reduced oxygen packaging may be held cold for the stated period under a county HACCP plan.

"Commercially processed hard, semisoft or pasteurized process cheeses, held for up to 30 days at 41F or less"

County Approved HACCP Plan, undated (file name 20201105_HACCP Quick Guide)

Acidification of sushi rice needs a state-issued variance.

"Acidification of sushi rice."

Processes Requiring a State-issued Variance, undated

Operators planning to cure meat or fish must first consult the Wake County Curing Process Application.

"If you are planning to cure meats or fish in the restaurant, please refer to the Wake County Curing Process Application first."

Curing, undated

Curing to extend shelf life or for shelf stability needs a state-issued variance.

"Curing to extend shelf life or for shelf stability"

Processes Requiring a State-issued Variance, undated

The county curing application lets the reviewer mark that the process requires a variance, in which case the process must stop until a variance is obtained.

"Process requires a Variance. Discontinue process until variance is obtained."

Application to use Curing Salts, approval block, undated (file name 20201105_Curing Application)

Smoking as a form of preservation needs a state-issued variance.

"Smoking as a form of preservation."

Processes Requiring a State-issued Variance, undated

Every Wake County HACCP plan must control for Listeria monocytogenes and Clostridium botulinum.

"It is REQUIRED that each HACCP plan control for Listeria monocytogenes, and Clostridium botulinum."

Hazard Analyses, undated (file name fillable_HACCP Application_6_20_16; text cites the 2009 NC Food Code)

All equipment must be ANSI-certified, and specification sheets for specialized equipment must be attached.

"All equipment must be ANSI-certified. Attach specification sheets for all specialized equipment that will be used to the end of the application."

Equipment List (REQUIRED), undated (file name fillable_HACCP Application_6_20_16; text cites the 2009 NC Food Code)

Labels must be moisture resistant and last for the stated number of days.

"You must print labels that are moisture resistant that will last 14 days."

Labeling, undated (file name fillable_HACCP Application_6_20_16; text cites the 2009 NC Food Code)

Inspectors check that a HACCP plan was submitted to the regulatory authority before the establishment began a reduced oxygen packaging operation under the Food Code ROP section.

"HACCP plans were submitted to the regulatory authority prior to conducting a ROP operation that conforms to procedures within §3-502.12."

Item 29, IN/OUT, April 2024

For a chain establishment, the HACCP plan for vacuum packaging raw meat is approved at the state level, with no variance needed.

"Vacuum packaging of raw meat at a chain establishment (held <41F for <30 days) Yes-STATE No"

Decision chart, row: Vacuum packaging of raw meat at a chain establishment, undated

For a chain establishment, the cook-chill HACCP plan is approved at the state level, with no variance needed.

"Cook-Chill at a chain establishment (following a previous cooling/storage method) Yes-STATE No"

Decision chart, row: Cook-Chill at a chain establishment, undated

For a chain establishment, the sous vide HACCP plan at standard cooking temperatures is approved at the state level, with no variance needed.

"Sous-Vide at a chain establishment (cooked to standard final cook temp and held/stored using temps same as cook-chill) Yes-STATE No"

Decision chart, row: Sous-Vide at a chain establishment, undated

The state HACCP application and supporting documents are sent to the NC HACCP Plan Review Committee in the state Food Protection Program.

"Environmental Health Section Food Protection Program/ NC HACCP PLAN REVIEW Committee 1632 Mail Service Center Raleigh, NC 27699-1632"

HACCP Application, submission instructions, undated (file name HACCP Application FINAL_2015May)

Approved HACCP plans may not be changed without prior Department review and approval, and are subject to periodic review.

"Approved HACCP plans are final and no changes or modifications may occur without prior review and approval by this Department."

HACCP Application, page two, undated (file name HACCP Application FINAL_2015May)

Variance requests go to a committee appointed by the Department that includes a food scientist and industry, state and local public health representatives.

"Variance requests shall be submitted to a committee including a food scientist and representatives from industry and state and local public health agencies appointed by the Department."

15A NCAC 18A .2658(1), amending Food Code 8-103.10, Eff. September 1, 2012; rule is necessary without substantive public interest Eff. July 20, 2019

Specialized processing methods such as smoking for preservation and curing need a variance from the regulatory authority first, and a HACCP plan may also be required as part of the variance request.

"When a Food Establishment wants to deviate from a requirement in the code, utilizes Specialized Processing Methods as specified in § 3-502.11 such as Smoking Food for Preservation, curing food etc. a variance must first be obtained from the regulatory authority. A HACCP plan may also be required as listed in ¶ 8-201.13(A) as part of the variance request."

Item 32, Variance obtained for specialized processing methods, April 2024

The state variance request form lists acidification such as sushi rice, smoking for preservation, curing, and reduced oxygen packaging among the variance types an operator can request.

"Type of variance requested: [ ] Acidification (e.g., sushi rice) [ ] Smoking Food for Preservation (e.g., meat, fish) [ ] Curing Food (e.g., sausage, corned beef, pickled herring) [ ] Reduced Oxygen Packaging (e.g., vacuum packaging, modified atmosphere packaging)"

Request for a Variance, Type of variance requested, DHHS 3603 Revised 5/15

Variance applications and all supporting documents go to the NC Variance Committee in the state Food Protection Program, and incomplete applications are returned without review.

"Environmental Health Section Food Protection Program/ NC Variance Committee 1632 Mail Service Center Raleigh, NC 27699-1632"

Request for a Variance, submission instructions, DHHS 3603 Revised 5/15

All supporting documentation must come with the variance application and incomplete applications are returned to the applicant.

"All supporting documentation must be submitted along with this completed application. Please contact your local Regulatory Authority (RA) for assistance in completing this application. Incomplete applications cannot be reviewed and will be returned to the applicant."

Request for a Variance, submission instructions, DHHS 3603 Revised 5/15

The regulatory authority may require additional scientific data, a validated process, or a certified laboratory challenge study showing food safety is not compromised.

"Additional scientific data, a validated process, or a challenge study by a certified laboratory as required by the Regulatory Authority, supporting the determination that food safety is not compromised by the proposal:"

Request for a Variance, page two, DHHS 3603 Revised 5/15

Any adjustment or deviation from an approved variance requires resubmitting the variance request to the committee.

"Any adjustment or deviation from the approved variance will require resubmission of the variance request to the NCVC."

Variance Agreement, DHHS 3603 Revised 5/15

North Carolina incorporates the FDA Food Code and its Supplement of a fixed edition by reference in its food establishment rules, without later amendments or editions.

"The 2017 Food Code and the accompanying 2017 Food Code Supplement, not including subsequent amendments and editions, established by the U.S. Department of Health and Human Services, Food and Drug Administration (hereinafter referred to as the "Food Code") are hereby incorporated by reference."

15A NCAC 18A .2650, Readopted Eff. October 1, 2021

The adoption-by-reference rule was readopted with a stated effective date (see quote).

"Readopted Eff. October 1, 2021."

15A NCAC 18A .2650, History Note, Readopted Eff. October 1, 2021

Inspection marks the establishment out of compliance when the approved variance is not kept at the establishment.

"This item is also OUT when the approved variance as specified in ¶8-103.12(A) is not kept at the food establishment."

Item 29, IN/OUT, April 2024

Monitoring records must be kept as the variance approval specifies and a copy of the variance must be kept on site for employees and inspectors.

"Monitoring records must be maintained as specified in the variance approval and be available upon request from RA during routine inspections or any other time the request is made by the RA. A copy of the variance must be maintained on site and conveniently located, such that it is available for review by appropriate food employees and the RA during routine inspections or any other time the request is made by the RA."

Variance Agreement, DHHS 3603 Revised 5/15

The HACCP application must include a statement that an updated signed copy of the approved plan will be kept on the premises for the regulatory authority.

"A statement that an updated, signed copy of the approved plan will be maintained on the premises for review by the Regulatory Authority (RA)."

HACCP Application checklist, plan verification and validation, undated (file name HACCP Application FINAL_2015May)

Sous vide cooked to the standard final cooking temperature and cooled and held like cook-chill needs a HACCP plan but no variance.

"Sous-Vide (cooked to standard final cook temp and cooled/held using temps same as cook-chill) Yes No"

Decision chart, row: Sous-Vide (cooked to standard final cook temp), undated

Sous vide cooked below the standard cooking temperatures and held cold for a short period needs both a HACCP plan and a variance.

"Sous-Vide (cooked to lower than standard cook temps, held for <7days, held at <41F) Yes Yes"

Decision chart, row: Sous-Vide (cooked to lower than standard cook temps), undated

Cook-chill cooled to and held at the lower refrigeration temperature for up to the stated period needs a HACCP plan but no variance.

"Cook-Chill (cooled to 34F and held at or below 34F up to 30 days) Yes No"

Decision chart, row: Cook-Chill (cooled to 34F), undated

Cook-chill cooled to and held at the standard cold holding temperature for up to the stated period needs a HACCP plan but no variance.

"Cook-Chill (cooled to 41F and held at or below 41F up to 7 days) Yes No"

Decision chart, row: Cook-Chill (cooled to 41F), undated

Except for fish, no HACCP plan is needed for reduced oxygen packaging of a TCS food that is labeled with time and date, cold held, and taken out of the package within a short window after packaging.

"Except for fish a HACCP plan is not required when a TCS food is packaged using a reduced oxygen packaging method and is labeled with production time and date, held at required cold holding temperature, and removed from ROP packaging within 48 hours after packaging at the food establishment."

Item 29, Compliance with variance, specialized process, reduced oxygen packaging criteria or HACCP plan, NOTE, April 2024

In the state decision chart (columns: process, HACCP, variance), vacuum packaging raw meat held cold for a limited time needs a HACCP plan but no variance.

"Vacuum packaging raw meat (held <41F for <30 days) Yes No"

Decision chart, row: Vacuum packaging raw meat, undated

Vacuum packaging cooked foods held cold for a short period needs both a HACCP plan and a variance.

"Vacuum packaging of cooked foods (held <41F for <7 days) Yes Yes"

Decision chart, row: Vacuum packaging of cooked foods, undated

Vacuum packaging food for a short refrigerated hold needs neither a HACCP plan nor a variance.

"Vacuum Packaging food <48 hours. Refrigerated (41F or less) storage only. No No"

Decision chart, row: Vacuum Packaging food <48 hours, undated

Vacuum packaging raw seafood that stays frozen before, during and after processing needs a HACCP plan but no variance, and the variance committee will not approve reduced oxygen packaging of cooked seafood.

"Vacuum packaging raw seafood (held frozen before, during, and after processing) Yes No Variance committee will not approve ROP of cooked seafood products."

Decision chart, row: Vacuum packaging raw seafood, undated

Acidification of sushi rice needs both a HACCP plan and a variance.

"Acidification of sushi rice Yes Yes"

Decision chart, row: Acidification of sushi rice, undated

Curing under refrigeration following the cure manufacturer's instructions needs neither a HACCP plan nor a variance.

"Curing (Following manufacturer's instructions under refrigeration, using something like Prague Powder) No No Curing App & Log"

Decision chart, row: Curing (Following manufacturer's instructions under refrigeration), undated

Curing to extend shelf life or outside refrigeration needs both a HACCP plan and a variance.

"Curing to extend shelf life, outside of refrigeration, etc. Yes Yes"

Decision chart, row: Curing to extend shelf life, undated

North Carolina's amendments to Food Code Chapter Three are limited to the listed items (out-of-state sources and deletions of two sections), so the reduced oxygen packaging and variance sections of Chapter Three apply as written in the adopted edition.

"The provisions of this Rule make amendments, additions, and deletions to the Food Code incorporated by reference in Rule .2650 of this Section. In Chapter 3, the following apply:"

15A NCAC 18A .2653, Amended Eff. October 1, 2021

Plans for franchised or chain establishments are reviewed by the state Environmental Health Services Branch, while plans for independent establishments go to the local health department.

"Plans drawn to scale for franchised or chain food establishments shall be submitted for review and approval to the Environmental Health Services Branch, N.C. Division of Public Health. Plans drawn to scale for independent food establishments shall be submitted for review and approval to the local health department."

15A NCAC 18A .2658(2), amending Food Code 8-201.11, Eff. September 1, 2012; rule is necessary without substantive public interest Eff. July 20, 2019

Inspectors treat smoking, curing, reduced oxygen packaging, additives that make a food non-TCS, cook chill and sous vide as specialized food processes and review the related SOPs and HACCP records.

"a discussion with the PIC to determine if there are specialized food processes [i.e. smoking food, curing food, reduced oxygen packaging, using food additives to render a food so that it is not TCS food, cook chill, sous vide, etc.] and the record review of standard operating procedures and HACCP documentation."

Item 29, IN/OUT, April 2024

A specialized process found running without regulatory approval must stop at once and the food from it may not be sold or served.

"The specialized process must stop immediately, and no food involved in that process may be sold or served."

Item 29(a), April 2024