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Food Safety Variance

Requesting a Variance to the Food Sanitation Rules

Restaurants must have a variance approved by the Oregon Health Authority (OHA) before starting any specialized processing, such as curing, vacuum-packaging, canning or acidifying foods as described in OAR 333-150-0000 Chapter 3-502.11

Keep in mind variances are not intended for facilities that do not meet rules.  They are for facilities that can show that the rules present an undue burden to their operation and that their proposed alternative will provide public health protection equal to or greater than the measures provided for in the current rules.  All variance applications must be approved before the procedure is put into practice.

If you have facilities located in several locations statewide, send your application directly to the Oregon Health Authority, Foodborne Illness Prevention Program, 800 NE Oregon St, Suite 640, Portland, OR 97232. If you have only one location, send your application to the Local Public Health Authority, and they will forward your form to the State Foodborne Illness Prevention Program for evaluation.

 

Meat Processing (curing/fermenting/smoking for preservation or adding nitrates/nitrites)

Operators curing/smoking ham or sausage, making jerky or fermenting meat/sausage, must meet the guidelines set forth in the Association of Food and Drug Officials Protocols.  Applications that do not meet the AFDO guidelines will not be considered.  Operators adding nitrates or nitrites to meat products, must meet the requirements of 21 CFR 172.175Operators granted a variance for meat processing may only use the product in the restaurant and may not package for retail sale.

For more on meat processes, the University of Wisconsin Center for Meat Process Validation has a lot of helpful information.  And to learn more about food safety concerns with cured and smoked meats here.

 

Acidified Foods (hermetically sealed/shelf stable)

Remember:  You can avoid a variance by having a licensed copacker make and package your food for retail sale.  Before you choose a copacker for your product, here is some guidance for use in the selection and contracting process.

To Proceed with an Acidified Food Variance:

1)  Have product tested for pH at an approved food testing lab

2)  Send recipe and pH results to Process Authority for evaluation

3)  Submit Process Authority letter, variance application, and all test results to Oregon Health Authority (OHA) for evaluation

4)  If the product is determined to be an acidified food, the operator needs to successfully complete Better Process School and schedule their process with the FDA in accordance with 21 CFR 114. For more information on Better Processing School or to find a process authority for your acidified food product, contact:

 

Canning Fruit Jams and Jellies for Retail Sale--NO VARIANCE REQUIRED

In Oregon, these products are covered under the Combination Facilities Agreement with the Department of Agriculture.  However, there are requirements the operator must meet:

  • Facility needs to meet 21 CFR 150-Standards of Identity
  • Product must be properly labeled if retailed
  • Facility must send sample to lab for BRIX/TSS (total soluble solids) test.  There are several food testing labs in Portland to choose from. The required parameters are listed in the Standards of Identity for each product.
  • The operator should keep the lab results on file in the facility (and should re-test if recipe changes)

Examples of Special Processes and Required Regulation

House-made
Product Examples
Within code, so no additional requirements or paperwork HACCP Plan must be submitted to County Environmental Health Before Starting Process Variance application and HACCP Plan must be approved by the State Oregon Health Authority Before Starting Process

Bacon, Corned Beef

Special Process: Curing Nitrites/Nitrates
See Fact Sheet #3

Health Concerns with Process:
Nitrites/nitrates are federally regulated under 21 CFR 172.170 and 175.

Jamaican Villa - Saltpetre


  • Use of a natural cure consisting of sugar, salt and spices or natural colorings like paprika and celery salt.
      
Not applicable

  • Use of a commercial cure for flavor/color with 7-day datemark of final product, and/or;
  • To extend shelf life of product and/or use of non-commercially prepared salt cure (ex: nitrite powder).
  • See Processing Guidance #1

Prosciutto, Summer sausage, Jerky

Special Process: Curing-Drying
See Fact Sheet #3

Health Concerns with Process:
France Salaisons du Lignon Dried Sausage - Salmonella

Uncooked, Semi-Dry Fermented Sausage -Non O157 E. coli

Sausage and Jerky - E. coli O157:H7


  • Using a brine/rub of natural ingredients, with product dried under refrigeration with 7-day datemark of final product.


Not applicable


Breaking down bulk package of raw steaks into single serving vacuum packages

Special Process: Reduced Oxygen Packaging-Vacuum Packaging
See Fact Sheet #2


  • Food stored in sealed bag for 48H or less.
  • Inspectors - See Guidance #02-12


Marinating meats prior to bagged cooking

Cooling bulk batches of soups/sauces in vacuum packages

Special Process: Reduced Oxygen Packaging -Sous Vide/Cook Chill
See Fact Sheet #4


  • Food stored in sealed bag for 48H or less.
  • Inspectors - See Guidance #02-12


Jams, Pickles, Salsa

Special Process: Reduced Oxygen Packaging - Canning

See Fact Sheet #22
See Fact Sheet #23

Health Concerns with Process:
Botulism from home canned beets

Castleberry's Hot Dog Chili Sauce​


Jams/jellies if:
  • Product meets 21 CFR 150 - Standards of Identity
  • Product is properly labeled if retailed: Oregon Food Safety website
  • Facility must send sample to lab for BRIX/TSS test. The required parameters are listed in the Standards of Identity for each product.
  • The operator should keep the lab results on file in the facility (and should re-test if recipe changes)


Not applicable


  • Pickles, salsas and sauces are frequently acidified foods. These are subject to federal regulation if they are a sealed, shelf-stable product
  • See Processing Guidance #5
  • If the product is a shelf-stable acidified food, a license by Oregon Department of Agriculture will be required instead of a variance from OHA.

BBQ Sauces, Marinades, Dressings

Special Process: Reduced Oxygen Packaging - Bottling Sauces for Retail Sale

See Fact Sheet #22


1) Unsealed bottles, held at 41F with 7day datemark and properly labeled


2) Unsealed bottles, extended shelf life under refrigeration:


a. Provide pH sample results of product from an approved food testing lab and have a water activity and pH that demonstrate the product to be non-potentially hazardous

b. Operator must keep all product under refrigeration and label 'Keep Refrigerated'

c. Operator must submit sample to lab to determine shelf life of product

d. Product must be properly labeled for retail sale


Not applicable


  • Any hermetically sealed, shelf stable product
  • See Processing Guidance #5
  • If the product is a shelf-stable acidified food, a license by Oregon Department of Agriculture will be required instead of a variance from OHA.

Alfalfa Sprouts, Mung Bean Sprouts

Special Process: Sprouting Seeds/Beans


See Fact Sheet #14

Health Concerns with Process:
Multistate Outbreak of Salmonella Enteritidis Infections Linked to Bean Sprouts

Multistate Outbreak of Human Salmonella Newport Infections Linked to Raw Alfalfa Sprouts

Multistate Outbreak of Shiga toxin-producing Escherichia coli O121 Infections Linked to Raw Clover Sprouts


Not applicable



  • If all product will be cooked to at least 165F prior to service
  • If product will be served raw or lightly cooked.
  • See Processing Guidance #6

Sushi Rice, 1000 Island Dressing

Special Process: On Site Acidification

See Fact Sheet #22


  • Combining all non-potentially hazardous (naturally acidic) ingredients together to hold at room temp for use.


Not applicable


  • If acid is added to a product to render it non-hazardous and it is held at room temperature longer than the 4 hours allowed in rule and/or reduced oxygen packaged.
  • See Processing Guidance #7

All Other Processes

Special Process: All processes not addressed above


Not applicable


Not applicable


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