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    Resources for Food Processing Facilities

    Regulatio​ns 

    Does my facility need to be licensed? 

    All food processing facilities as defined in COMAR 10.15.04.02 must be licensed as stated in COMAR 10.15.04.21 &  ​​​Md. HEALTH-GENERAL Code Ann. § 21-305.  Types of Licensed Food Processing Facilities include: food processing or manufacturing, on-farm processing and storage, seafood plants, crab meat picking plants,  shellfish​operations, canneries, soft drink and bottled water plants, warehouses, and food transportation vehicles.​All facilities must continue to have a current license to operate.  Facilities that operate without a license are subject to enforcement action. ​

    What State of Maryland regulations apply to my facility? 

    10.15.04 Food and Drink Processing and Transportation

    10.15.01 Low Acid and Acidified Food Canning

    10.15.02 Crab Meat​​

    10.15.07 Shellfish Sanitation​

    10.15.10 Procedures for the Safe Handling and Processing of Seafood​​

    10.15.11 Bottled Water​

    10.15.12 Procedures for the Safe Han​dling and Processing of Juice​

    ​Will my facility be inspected? How often?

    Food Processing Plants are inspected by Center for Food Processing (CFP) staff who are Licensed Environmental Health Specialists(LEHS) to ensure compliance with applicable State and ​Federal laws and regulations.  Inspection frequency is determined by a risk analysis conducted during plan and process review. The facility must be available for inspection to remain licensed. ​​

    What if a product is to be added or changed in my licensed facility?  What if equipment is added or the facility will be remodeled? 

    Plans must be submitted and approved if a food process is added or modified so that a plant or plant facilities require modification or process critical control points are added.  Plans must all be submitted if a facility is remodeled or materially altered.  Contact the Center for Facility and Process Review (FAPR) ​to determine the next steps. 

    What if the facility will be moving? 

    Plans and specifications must be submitted and approved  before a food processing plant is constructed, remodeled, materially altered, or an existing building or structure is converted or remodeled for use as a food processing plant.  Contact the Center for Facility and Process Review (FAPR) ​to determine the next steps. 

    Does my facility fall under FDA jurisdiction? What does that mean for my facility?

    Facilities that manufacture, process, pack, and hold food and operate(receive or distribute) across state lines fall under FDA jurisdiction and must comply with the Code o​​f Federal Regulations (21 CFR 117)  Other facilities may also need to register, comply with portions of the regulation, or attest that they are exempt.

    Facilities may be inspected by FDA staff or by CFP staff that are credentialed by FDA as part of a cooperative program between MDH & FDA. 

    Does my facility need to comply with the Food Safety Modernization Act(FSMA) or the PC Rule? 

    To find out which portions of the Food Safety Modernization Act apply to your facility please see our FDA,FSMA, and the PC Rule​​ page.


    Guidance Documents​​

    Employee Training -- Coming Soon

    Standard Operating Procedures (SOPs)  ​​​

    Sanitation Standard Operating Procedures(SSOPs)  ​

    Food Allergy Awareness  

    Controls for Allergens  ​​

    Elements of a Recall Plan  

    ​​Manufactured Foods: Sanitation Verification for Listeria 

                       English     Spanish     Arabic     French     Chinese     Korean     Russian     

    Listeria Factsheet for Produce Plants

                       English     Spanish     Chin​​ese (simplified)  Chinese​ (traditional)​  Korean​     ​​


    More Resources

    Hand Washing from the CDC


    Covid-19 Resources​

    ​​MD Business Resources​  

    CDC Business Resources​  

    Covid-​19 Confirmed Workers  

    Employee Health and Food Safety Checklist  


    Export Certificates 

    For an Export C​ertificate or Free Sale Certificate proceed to the FDA Online Export ​Certificate Application website.  

    For Certificates of Health, Certificates of Origin and Health, and GMP Certificates, please contact the Center for Food Processing at (410)767-8400 or mdh.envhealth@maryland.gov​​​.



    ​This page was last updated 11.19.2021