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.

To Apply - Restaurants Conducting Special Processes

Please fill out the Variance Application Form (pdf) and send your application packet and $500 application fee directly to the Oregon Health Authority, Foodborne Illness Prevention Program, 800 NE Oregon St, Suite 640, Portland, OR 97232. In the charts below you can find specific checklists of what needs to be sumitted for each process as part of the application packet.

To Apply - Mobile Food Units Asking to Cater

Please fill out the Variance Application Form (pdf), and send the information requested on the checklist along with the $500 application fee directly to the Oregon Health Authority, Foodborne Illness Prevention Program, 800 NE Oregon St, Suite 640, Portland, OR 97232.

Common Processes

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 172.175. Operators granted a variance for meat processing may only use the product in the restaurant and may not package for retail sale.

Niche Meat Processor Assistance Network has tools and information for small meat processors in Oregon.

For more on meat processes, the University of Wisconsin Center for Meat Process Validation has a lot of helpful information. Learn more about food safety concerns with cured and smoked meats at the National Center for Home Food Preservation.

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 (pdf) for use in the selection and contracting process.

To Proceed with an Acidified Food Variance:

Have product tested for pH at an approved food testing lab
Send recipe and pH results to Process Authority for evaluation
Submit Process Authority letter, variance application, and all test results to Oregon Health Authority (OHA) for evaluation
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:
- Oregon State University
- Washington State University
- Chapman University-Orange, CA for courses in English and Spanish
- New Mexico State University-Las Cruces, NM for courses in English and Spanish

Canned 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	For drying meats at room temperature drying and/or extended shelf life of final product See Processing Guidance #2
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	Packaging raw meats, vegetables, cheeses. See Processing Guidance #3a Inspectors - See Guidance #01-15	To hold packaged foods beyond 14 days and /or packaging of cooked foods See Processing Guidance #3
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	If following the provisions in 3.502.12. See Processing Guidance #4a Inspectors - See Guidance #01-15	To extend shelf life and/or if they cannot provide continuous electronic monitoring of refrigeration. See Processing Guidance #4
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	See Processing Guidance #8