A Step-by-Step Guide to On-Farm Processing of Acidified Foods

The SMADC ‘Step by Step Guide’ is a comprehensive resource for those interested in selling ACIDIFIED FOODS (pickles) directly to consumers at farmers markets, stores, and restaurants. It provides all the information you’ll need to get started and guide you through the process to obtain the Maryland Department of Health (MDH) On-Farm Home Processor License for acidified foods.

Acidified foods are low-acid foods to which acids or acid foods are added to achieve a finished equilibrium pH of 4.6 or below. Typically, these products include a variety of vegetable pickles such as pickled beets and cucumbers and many types of sauces, condiments, dressings, chutneys and relishes.  

All processors (farmers/on-farm, large and small food entrepreneurs) who want to make and sell acidified food products in Maryland must be licensed by the Maryland Department of Health (MDH). The On-Farm Home Processing License may be issued to eligible farmers/producers for product sales less than $40,000 annually.

Learn more about Processing and Selling Value Added Food Products in Maryland – This MDH guidance will help you find out which foods require the On Farm Home Processor License (acidified and other processed foods), plus other important information (license fees, and production limits).

Step 1: Attend an Approved FDA Foods Better Process Control School Class for Acidified Foods

You must successfully complete an approved FDA Better Process Control School Class (BPCS) for Acidified Foods before engaging in the commercial production of acidified foods; this is a requirement of both the Food and Drug Administration (FDA) and the Maryland Department of Health (MDH) Search the web to find BPCS virtual and in person classes offered through many state universities and educational institution food science departments.

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Step 2: Check your Water Supply

Proof of potable water supply is required by MDH; your water must be tested. Provide a current water test certificate.   Contact your county Health Department for Water Sample Requests. Most local health departments will collect and test a water sample; a fee may be charged.

If your farm has a shallow well, you may be permitted to use water from an alternative approved water source. This example of STANDARD OPERATING PROCEDURES (SOP’s) is documented to show how potable water may be safely transported from an approved water source to your farm kitchen.

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Step 3: Apply for MDH On-Farm Home Processing License

Visit MDH Center for Facility and Process Review for application requirements:

• On-Farm Processing Plan Review Guidelines
• MDH On-Farm Home Processing Licensing Procedure Step-by-Step Guide

Download the Plan Review Submission Form Complete the following sections for On-Farm Home Processing:

• Check ‘On-Farm Processing’ under Project Description and Applicable Fees
• Complete Site Information as applicable
• Contact Information – complete ‘Owner/Operator’ section
• Attach Standards of Procedure and other required information detailed in the On-Farm Processing Plan Review Guidelines (1 – 7).
• Submit application as directed on form.
• No fee is required until approval/inspections are completed

MDH Resources for developing processing plans and procedures:

• Developing Sanitation Standard Operating Procedures (SSOPs)
• Developing a Recall Plan
• Developing Standard Operating Procedures

When your plan submission has been reviewed and the application requirements are satisfactory, MDH will schedule an inspection of your on-farm kitchen to ensure it meets food safety and sanitation requirements (See Step 9). Upon completion of all plan review requirements, an approval letter and license application will be issued.

Note: Re-inspection may be required to verify corrections specified in the plan review inspection report have been completed.

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Step 4: Register with FDA– FDA Establishment Registration & Process Filing for Acidified Foods (LACF)

You must register with FDA before you start processing and selling any acidified food products. 

1) FDA Food Canning Establishment Registration: All commercial processors of acidified foods must submit FDA Form 2541 to register their on-farm kitchen (or processing facility). This form may be submitted on paper or electronically. FDA will assign you a Food Canning Establishment number (FCE#). The FCE number identifies your on-farm kitchen and must be used when you file your recipes with the FDA.

To register on-line:
Create an on-line account with FDA at: www.access.fda.gov

CLICK HERE FOR FULL FDA ELECTRONIC SUBMISSION ESTABLISHMENT REGISTRATION GUIDELINES

To register on paper:
Print and complete the FDA Form 2541.

CLICK HERE FOR FULL FDA PAPER SUBMISSION ESTABLISHMENT REGISTRATION GUIDELINES

To request a printed FDA Form 2541 and for more information email the LACF Registration Coordinator at: LACF@FDA.HHS.GOV, or write to this address: LACF Registration Coordinator, Food and Drug Administration (HFS-303), 5100 Paint Branch Parkway, College Park, Maryland 20740.

2) FDA Food Facility Registration: Since December 2003, nearly all food processing facilities must register under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. *Farms DON’T have to register; See Small Entity Compliance Guide here: https://www.fda.gov/media/85098/download

*These Facilities DON’T Have to Register:

• Primary production farm — i.e., an operation under one management in one general (but not necessarily contiguous) physical location devoted to the growing of crops, the harvesting of crops (washing, trimming outer leaves, and cooling produce are part of harvesting), the raising of animals (including seafood), or any combination of these activities. The term “primary production farm” can include operations that pack or hold raw agricultural commodities, pack or hold processed food, or manufacture/process food under certain circumstances.
• Secondary activities farm – i.e., an operation, not located on a primary production farm, devoted to harvesting, packing, and/or holding of raw agricultural commodities, as long as certain ownership criteria are met. A secondary activities farm may also pack or hold processed food or manufacture/process food under certain circumstances.

Visit the FDA website to review Food Facility guidelines. For more information contact the U.S. Food and Drug Administration Help Desk at 1-800-216-7331 or 240-247-8804 (Monday to Friday from 7:30 am to 11:00 pm Eastern Standard Time) or write to this address: U.S. Food and Drug Administration, HFS-681, 5001 Campus Drive, College Park, MD 20740.

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Step 5: Record and Document Information about on Your Recipe/s

We recommend recording all the steps and process for your product recipes (raw ingredients, method, time, temperature, etc); this information may be requested by MDH, and when you submit your recipe to a *Process Authority for review. (*Step 7).

(EXAMPLE RECIPE)

You will need special equipment to accurately measure and record pH levels, weights, and temperatures. Below are suggested equipment and supplies: 

• A pH meter (for food)
• pH buffers, cleaning, and storage solutions (for pH meter maintenance)
• Chlorine/Sanitizing test strips (to check sanitizing solution chlorine levels – make sure the strips are not for swimming pools!)
• A digital thermometer
• A digital scale
• A clock or digital timer

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Step 6: Create a Label for Your Products

All acidified foods products sold in Maryland must at a minimum be labeled with the farm/facility name and address of the producer, the identity of the product and quantity statement (ingredients, net weight). Ingredients must be listed in weight order (largest to least).

An additional label is recommended showing your FDA Food Canning Establishment number (FCE#) MDH License number and product batch identification number.

(SAMPLE LABEL)

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Step 7: Process Authority Recipe Review 

You will require a recognized Process Authority (a person with expert knowledge in the acidification and processing of acidified foods) to review, document, validate and approve the safety and stability of your recipe. The Process Authority will provide a Scheduled Process detailing your recipe (ingredients, procedure, and critical control points) which must be submitted to the FDA (Step 8.) and MDH.

Process Authority services are provided by many certified food testing laboratories and university/college food science departments of universities. 

Cornell Food Venture Center/Food Research Lab may be able to provide comprehensive assistance to beginning and established Maryland on-farm food producers (as funding/staff allows). Cornell Process Authority will review your submitted recipe and sample and provide a Scheduled Process. Please contact Cornell for current prices, availability of service and recipe submission details.

Cornell Food Venture Center

Cornell University/NYSAES
Food Research Lab
630 W. North St.
Geneva, NY 14456

Phone: (315) 787-2273 / 787-2397

cfvc@cornell.edu

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Step 8: Submit your recipe to the FDA

When you receive the Process Authority letter of approval and the Scheduled Process for your recipe, complete FDA Form 2541E using the critical factors and other process information described in the Scheduled Process.

To file your recipe on-line:
If you have already created an on-line account with FDA, you must log on to your account and follow directions to file your process on-line.

To file by mail (paper filing only):
Mail completed FDA Form 2541E with a copy of the Process Authority letter of approval and scheduled process to the FDA.

Click here for FDA 2541E PAPER SUBMISSION GUIDELINES. No fee is required for submitting/filing your recipe/s.

To request a printed copy of FDA Form 2541E, contact LACF Registration Coordinator at 240-402-2411, or write to:

LACF Registration Coordinator (HFS-303),
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740

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Step 9: MDH On-Farm Processing Review and Licensing

On receipt of your Plan Review Application (Step 3), MDH Plan Review Specialists will review your plans and schedule a visit to your farm to inspect your kitchen.

You will be required to demonstrate your knowledge and ability to execute the sanitation and process requirements. MDH will observe the production of your recipe and all record keeping as stated in your plans and Scheduled Process. Note: Re-inspection may be required to verify any corrections, as specified in the plan review inspection report, are completed.

Upon completion of all plan review requirements, an approval letter and license application will be issued ($30, renewable annually).

Licensed On-Farm Home Processors will be reviewed annually on or before their license renewal date. All new recipes with associated paperwork (Scheduled Process, product labels, standard operating procedures) must be submitted to MDH for review and approval before you can start commercial production.

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Step 10: Maintain Accurate Records!

Keep all your records (license, BPCS certificate, process authority reviews, FDA forms, logs, etc.) together in one place, preferably in a binder. You may receive a visit from FDA or MDH inspectors at any time during the year to observe your process and/or inspect your processing kitchen and review all processing records/logs.

You are required to:

• Submit to MDH all new recipes with associated paperwork (Scheduled Process, product labels, SOP’s) for review and approval before you start commercial production.
• Submit FDA Form 2541E for each new acidified foods recipe.
• Record/Complete a ‘Processing Log’ each time you process a recipe/batch for sale. (SAMPLE PROCESSING LOG)
• Keep your records/production logs up to date and available for inspection.
• Test your water supply annually.

These are examples of additional record keeping logs which may be required by DHMH/FDA:
Recall Procedure Log
Customer Complaint Log
Calibration Log
Corrective Action Log
Product Distribution Log