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

Do you want to sell your pickled beets and other Acidified foods at a Farmers’ Market or to stores and restaurants? The SMADC ‘Step by Step Guide’ has everything you need to get started, complete with sample forms and important contact information to help you along the way to becoming a licensed on-farm processor of acidified foods.

In order to make and sell Acidified Foods direct to consumer or retail/wholesale in the State of Maryland, producers must be licensed by the Department of Health and Mental Hygiene (DHMH). The On-Farm Processing License may be issued to eligible farmers/producers with product sales less than $40,000 annually. For more information about the Code of Maryland Regulations (COMAR) governing the production of Acidified Foods visit Division of State Documents/COMAR.

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 and Mental Hygiene (DHMH).

A list of nationally approved BPCS classes can be accessed on the Grocery Manufacturers Association (GMA) website.Search under BPCS for the annually updated list, or check out SMADC’s FarmLINK website Workshops and Events Page for news on upcoming BPCS classes in Maryland. 

Use this chart to find out which foods require an on-farm processor license (acidified and other processed foods), plus other important DHMH guidelines (license fees, and production limits).

For the latest information and updates, visit the DHMH website or contact:

DHMH Center for Facility and Process Review
6 St. Paul Street, Suite 1301,
Baltimore, MD 21202.
(410) 767-8400

 

Step 2: Check your Water Supply

Proof of potable water supply is required by DHMH; your water must be tested. Provide a current water test certificate. Click here for a list of water testing companies.

If you have a shallow well, you may be permitted to use 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.

 

Step 3: Apply for DHMH On-Farm Processer Plan Review Package 

Contact the DHMH Center for Retail Food, Plan and Process Review at (410) 767-8400 to apply for a plan review package and Plan Review Submission Form. Click here for the DHMH step-by-step licensing procedures.

Your kitchen must be inspected and certified. Inspection will include an evaluation of the farm kitchen to ensure that it meets all applicable health, food safety and sanitation requirements.   

 

Step 4: Register with FDA– Food Facility Registration

You must register with FDA before you start processing and selling any acidified food products. There are two required registrations which must be completed:

1.) FDA Food Facility Registration: Since December 2003, nearly all food processing facilities must submit FDA Form 3537 to register under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

To register by mail: First complete the FDA Form 3537. FDA is allowing registrants to submit Food Facility registrations on paper by mail or fax. Download form, complete and send to: U.S. Food and Drug Administration, HFS-681, 5100 Paint Branch Parkway, College Park, MD 20993, or FAX to (301) 436-2801. FDA will enter these submissions into its registration system as soon as practicable, in the order received.

To request FDA Form 3537, contact the U.S. Food and Drug Administration Help Desk at 1-800-216-7331 or 301-575-0156 (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, 5600 Fishers Lane, Rockville, MD 20857.

To register on-line: Visit the FDA website, select Food Facility/Online Registration of Food Facilities, then follow FDA guidelines for Food Facility Registration.

AND 

2.) FDA Food Canning Establishment Registration: All commercial processors of acidified foods must submit FDA Form 2541 to register their processing plant (or on-farm kitchen) with FDA. This form may be submitted on paper or electronically. 

To register on paper: Print and complete the FDA Form 2541FDA will assign you a Food Canning Establishment (FCE) number. The FCE number identifies your on-farm kitchen and must also be used when you submit acidified foods recipes for filing with the FDA. (Allow approximately 2 - 3 weeks for your number to be sent to you.) CLICK HERE FOR FULL FDA PAPER SUBMISSION GUIDELINES.

To request FDA Form 2541 and for more information,  contact the LACF Registration Coordinator at at 240-402-2411, or
e-mail: 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.

To register on-line: If you have already created an on-line account with FDA, you must log on to your account and follow directions register on-line. CLICK HERE FOR FULL FDA ELECTRONIC SUBMISSION GUIDELINES

 

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

We recommend that you test and record all the steps and process data for each of your product recipes. First, write down your recipe ingredients and describe the method for making your product. (example recipe)

Next, make a test batch of your recipe. Use the SMADC Recipe Evaluation Form to help you record critical data and measurements that you may need for DHMH to approve your process. The SMADC Recipe Evaluation Form may be used for pickled beets and other acidified foods. Please note, the recipe evaluation form is suggested guidance only. DHMH, your Process Authority and/or FDA may request additional data.

You will need special equipment to accurately measure pH levels, weights and temperatures. Below are items to consider. Click here for a list of suppliers.

  • A pH meter

  • pH buffers & cleaning solutions

  • Chlorine/Sanitizing test strips

  • A tape measure or ruler

  • A thermometer

  • A digital scale

  • A clock or digital timer

  • Water Tank (only required for transportation and storage of alternative potable water supply)

Step 6: Create a Label for Your Products

All acidified foods products sold in Maryland must at a minimum 
be labeled with the name and address of the producer, a quantity statement (ingredients, net weight) and the identity of the product.  (sample label)

Ingredients must be listed in weight order (largest to least). 
An additional label is recommended showing your FDA Food Canning Establishment number (FCE#) and batch identification number.

 

Step 7: Process Authority Recipe Review and Approval

You will require the assistance of a recognized Process Authority (a person with expert knowledge in the acidification and processing of acidified foods) to approve the safety of your recipe and develop a scheduled process to submit to the FDA. [what is a scheduled process?] 

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 has a Process Authority on staff who can review your submitted recipe, make any revisions necessary to comply with regulations and good manufacturing practices, develop a Scheduled Process and write an official letter of approval. A fee of $135.00 is required for initial registration and one recipe submission to Cornell Food Venture Center; thereafter the cost will be $67.50 per each unique recipe submitted for review. Registration/review fees are subject to change. Please contact Cornell for current prices and availability of service.

To submit your recipes to Cornell (Process Authority) for review, use the data recorded from your test batch (see SMADC Recipe Evaluation Form) to complete the Cornell's Scheduled Process Form for Acid, Acidified or Low Water Activity Foods.

Mail to Cornell Food Venture Center at the address below:

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

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

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 FULL 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

 

Step 9: DHMH On-Farm Process Review and Licensing

You will be required to demonstrate your knowledge and ability to execute the sanitation and process requirements for the production of acidified foods.

On receipt of your On-Farm Processer Plan Review Submission (Step 3), DHMH will review your recipe and process. A DHMH inspector will schedule a visit to your farm to inspect your on-farm kitchen and observe the production of your recipe and review all record keeping (processing logs). If successful, you will receive DHMH authorization to apply for an On-Farm Food Processor License ($30, renewable annually). DHMH will require copies of your Scheduled Process, completed FDA Form 2541e product labels and processing logs for their records. Note: Re-inspection may be required to verify corrections from the plan review inspection report.

 

Step 10: Maintain Accurate Records!

Keep all your records (licenses, certifications, process authority reviews, FDA forms, etc.) together in one place, preferably in a binder. You may receive a visit from FDA or DHMH inspectors at any time during the year to observe your process or inspect your on-farm kitchen.

You are required to:

  • Create labels for each of your products. (sample label)

  • Complete a ‘Processing Log’ each time you process a recipe for sale. (sample processing log)

  • Submit to FDA a Form 2541e for each new acidified foods recipe.

  • Submit to DHMH copies of each new recipe with Process Review and completed FDA Form 2541e.

  • Keep your records/production logs up to date and available for inspection.

  • Test your water supply annually. A current water certificate is required

These are examples of additional record keeping logs which may be required by DHMH/FDA:

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SMADC staff is available to advise and guide you through all the steps listed above. For information and assistance please contact Susan McQuilkin at: 301-274-1922, Ex. 1

SMADC ACIDIFIED FOODS SCHOLARSHIP
SMADC has provided scholarships (subject to the availability of funds) to assist producers with the cost of training at an approved FDA Better Process Control School Class (BPCS) hosted in Maryland by the Maryland Department of Agriculture. The SMADC scholarship award is integral to SMADC’s ongoing Acidified Foods initiative to enable increased opportunity for farms to profit through the manufacture of value-added farm products. To be eligible for the scholarship, applicants must be farmers/producers resident and farming in one of the five counties of Southern Maryland (Anne Arundel, Calvert, Charles, St. Mary's and Prince George's counties). For scholarship information, please contact Susan McQuilkin at: 301-274-1922, Ex. 1

 

*WHAT ARE ACIDIFIED FOODS? 
Acidified foods 
means low-acid foods to which acid(s) or acid food(s) are added; these foods include, but are not limited to, beans, cucumbers, cabbage, artichokes, cauliflower, puddings, peppers, tropical fruits, and fish, singly or in any combination. They have a water activity (aw) greater than 0.85 and have a finished equilibrium pH of 4.6 or below. These foods may be called, or may purport to be, ‘‘pickles’’ or ‘‘pickled lll.’’ Carbonated beverages, jams, jellies, preserves, acid foods (including such foods as standardized and nonstandardized food dressings and condiment sauces) that contain small amounts of low-acid food(s) and have a resultant finished equilibrium pH that does not significantly differ from that of the predominant acid or acid food, and foods that are stored, distributed, and retailed under refrigeration are excluded from the coverage of this part.

WHAT IS A SCHEDULED PROCESS?
A scheduled process is a process selected by a processor as adequate for use under the conditions of manufacture for a given product to achieve commercial sterility and/or maintaining a food that will not permit the growth of microorganisms having public health significance. Among other things, the scheduled process specifies the pH and other critical factors (such as heat processing, container type, ingredients and preservatives used) that must be controlled to assure the manufacture of safe acidified foods.  A scheduled process must be established by a qualified person or a competent process authority, with expert knowledge in the acidification and processing of acidified foods.  Scheduled processes must be followed during manufacture of the food, and critical factors must be monitored by an individual who has attended and successfully completed a course and has become certified to supervise those operations. 

 

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