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

Do you want to sell your pickled beets and otherAcidified foodsat 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 ofacidified foods.

In order to make and sell Acidified Foods direct to consumer or retail/wholesale in the State of Maryland producersmust be licensed by the Department of Health and Mental Hygiene (DHMH).The On-Farm Processing License may be issued to eligible farmer/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(Link to URL:

Usethis chart(replace PDF with attached: Processing and Selling Value Added Food Products in Maryland)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, visittheDHMH website(New link– or contact:

DHMH Center for Facility and Process Review

6 St. Paul Street, Suite 1301,

Baltimore, MD 21202.

(410) 767-8400

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

You must attendsuccessfully completeand pass 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 national list of FDA-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(link to URL: for news on upcoming BPCS classes in Maryland.

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 ofWATER TESTING COMPANIES(replace PDF with attached: Water Testing Companies)

If you have a shallow well, you may be permitted to use an alternative approved water source. Thisexample ofStandard 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 theDHMH step-by-step licensing procedures.(Replace PDF with attached: On-Farm Home Processing License Procedure Step-by-Step)

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 your on-farm kitchenwith FDA before you start processing and selling any acidified foodsproductsrecipes. There are two required registrations which must be completed:

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

To register by mail:First complete theFDA Form 3537.(New Link - 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 theFDA website, (NEW URL: select Food Facility Registration/Online Registration of Food Facilities,Module/create new account,then follow FDA guidelines for on-line Food Facility Registration. registration.

AND

2) FDA Food Canning Establishment Registration:All commercial processors of acidified foods must submitFDA Form 2541to register their processing plant (or on-farm kitchen) with FDA.This form is only accepted through the postal system and cannot be completed on-line!This form may be submitted on paper or electronically.

To registeron paper:(paper registration only):Print and complete theFDA Form 2541.FDA 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 (URL:

To request FDA Form 2541and for more information, contact the LACF Registration Coordinator at 240-402-2411301-436-2411, or email:, 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 havealready 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 (NEW URL:

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 theSMADC On-Farm Recipe Evaluation Form(Replace PDF with attached: Recipe Process Evaluation Form)to help you record critical data and measurements that youmaywillneed in order for DHMH a Process Authority to approve your process.,and to complete FDA form 2541A.The SMADC On-Farm Recipe Evaluation Formmay be used for pickled beets and other acidified foods.Please note,the recipe evaluation form is suggested guidance only.theDHMH, yourProcess Authority and/or FDA may request additional data.not itemized on this form.

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 andaddress of the producer, a quantity statement (ingredients, net weight) and the identity of the product.(sample label)

Ingredients must should 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 recognizedProcess Authority(a person with expert knowledge in the acidification and processing of acidified foods)to approve the safety of your recipe and develop ascheduled process to submit to the FDA. [what is a scheduled process?]

Cornell Food Venture Center/Food Research Lab ismay be able to provide comprehensive assistance to beginning and established Marylandon-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 aScheduled Processand 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 pricesand availability of service.

To submit your recipes to Cornell (Process Authority) for review,use the data recorded from your test batch (see SMADC On-Farm Recipe Evaluation Form) to complete the Cornell'sScheduled 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

Contact: Elizabeth Keller
Phone:(315) 787-2273 / 787-2397
Fax:(315) 787-2397
Email:

Step 8:Submit your recipe to the FDA

When you receive the Process Authority letter of approval and the Scheduled Process for your recipe, completeFDA FORM 2541eFDA form 2541A(New URL: using the critical factors and other process information described in the Scheduled Process.You may also need additional data from the SMADC On-Farm Recipe Evaluation Form. No fee is required for filing.

To file your recipe on-line:If you havealready 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 completedFDA FORM 2541eFDA form 2541A(New URL: a copy of the Process Authority letter of approval andscheduledprocessto the FDA.CLICK HERE FOR FULL FDA 2541e PAPER SUBMISSION GUIDELINES(URL:

No fee is required for submitting/filing your recipe/s.

To request a printed copy ofFDA FORM 2541eFDA form 2541A(New URL: contact LACF Registration Coordinator at 240-402-2411301-436-241, 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 FinalOn-Farm Process Reviewand Licensing

You will be required to demonstrate your knowledge and ability to safely execute theStandards of Procedure,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 Processing Plant License($30, renewable annually). DHMH maywill require also request copies of your Scheduled Process,completed FDA Form 2541e FDA form 2541A,product labels and processing record 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’eachtime you process a recipe for sale. (sampleprocessing log)(replace with attached PDF: Critical Control Log)
  • Submit to FDA an a Form 2541e FDA form 2541Ato the FDA for each new acidified foods recipe
  • Submit to DHMH copies of each newrecipewith Process Review and completed FDA Form 2541eFDA 2541A to DHMH
  • 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:

  • Product distribution log (Link to attached PDF: Production Distribution Log)
  • Corrective action log(Link to attached PDF: Corrective action log)
  • Calibration log(Link to attached PDF: Calibration log)
  • Customer complaint log(Link to attached PDF: Customer complaint log)
  • Recall plan/procedure(Link to attached PDF: Recall Procedure log)

SMADC staff is available to advise and guide you through all the steps listed above.If you attended the SMADC Better Process School which was facilitated by The Small Business Development Center at the College of Southern Maryland Prince Frederick Campus in the spring of 2008or UMD “Understanding Acidified Foods Workshop” in Loveville in the fall of 2010,you may be eligible to receive a grant to cover the cost of the initial registration and submission of one recipe with the Cornell Food Venture Center.For information and assistance please contact Christine Bergmark or 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 thefive 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 foodsmeans low-acidfoods 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.’’ 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 processis 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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