FOOD MANUFACTURING, PACKING, HOLDING AND DISTRIBUTION

Commercial Food Establishments

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Overview

This program covers businesses that store, package, make, cook, mix, process, bottle, bake, can, freeze, pack, or otherwise handle food. This includes a building, place, or vehicle used for these purposes.

Owners of such food businesses must first get a Food Registration. Those approved by the Department can label their products with "Reg. Penna. Dept. of Agr." Only PDA registered businesses can use this label. These food establishments follow Act 106 of 2010 (3 C.S §§5721 - 5737). This act includes all federal food regulations.

Most FDA food regulations are in Title 21 of the federal code. You can find the 21 CFR's linked below. However, companies with only milk permits are exempt from registration. Similarly, those under USDA/FSIS jurisdiction also don't need PDA registration.

All PA registered food establishments must comply with 21 CFR 117 Subpart B. It covers the GMPs for Human Food. There are no exceptions.

GMPs are the basic operational and environmental conditions required to produce safe foods. They ensure safe handling of ingredients, products, and packaging. Food must be made, processed, stored, and distributed in a clean, safe environment. GMPs addresses the hazards associated with personnel and environment during food production. They provide the foundation for any food safety system.

  • Generally, GMPs address the following areas:
  • Building and Facilities
  • Personnel Health and Practices
  • Sanitation and Controls
  • Equipment Maintenance
  • Production and Process Controls
  • Storage and distribution

To assess your operation's food safety for GMPs, use the Modernized GMPs Checklist for PA Food Establishments. It helps food establishments document their compliance with the standards. 

Seafood food distributors and processors must apply for a Food Registration. They must be inspected and found compliant before the Department can issue a Registration.

Seafood businesses must follow the Seafood HACCP regulation in 21 CFR 123. They must also meet the GMP requirements in 21 CFR Part 117.

Seafood processors must submit HACCP plans and hazard analyses for all products. If their analysis finds food safety risks, they need HACCP plans for each fish product before starting operations.

All FDA regulations, guidance, and training on Seafood HACCP are located here:

FDA Seafood HACCP Information

Juice and juice beverage processors must apply for a Food Registration. They must be inspected and found in compliance. Only then will the Department issue a Registration.

Juice or juice product wholesalers must meet the Juice HACCP regulation in 21 CFR 120. They must also meet the GMP requirements in 21 CFR Part 117. If HACCP applies, processors must conduct a hazard analysis. If their products are unsafe, they must have HACCP plans for each type of juice or juice product they are processing, before starting operations.

All FDA regulations, guidance, and training on Juice HACCP are at the link below.

FDA Juice HACCP Information

Producers of Acidified Foods (AF) and Low Acid Canned Foods (LACF) must apply for a Food Establishment Registration. Then, they need to pass an inspection. Only then will the Department issue the Registration. Processors must follow the federal regulations. For Acidified Foods, they refer to Part 114. For LACF, they must comply with Part 113. This part covers thermally processed low acid foods in sealed containers. Additionally, they must adhere to Part 108 for emergency permit control.

Processors of acidified foods and LACF for interstate commerce must register with the FDA. They must file scheduled processes through their process authorities. A qualified individual must supervise the operation. They can qualify through education, like the Better Process Control School, or relevant experience.

All FDA rules, guidance, and training on processing acidified and low acid foods are at the links below. They are on the FDA website.

All PDA registered food establishments must comply with the FSMA rules, unless exempted. For information about PDA requirements under FSMA rules, select FSMA tab from the Food Safety Home Page. You can also access the page directly here at: Food Safety Modernization Act page.

For more information about FSMA, visit the FDA here at: FDA website.

How to apply

Commercial food manufacturers, processors, distributors and warehouse to apply, you need to download or print Application Packet - Food Establishment Registration (PDF)

All material must be submitted at least 60 days prior to operating. Failure to provide all required information can delay and/or deny your plan review. Email is the preferred method of plan review submission.

Submit completed application and requested documentation to:

RA-AGPLANREVIEW@pa.gov

or mail / fax to:

Pennsylvania Department of Agriculture
Bureau of Food Safety and Laboratory Services
Attn: Plan Review
2301 N. Cameron St, Room 112
Harrisburg, PA 17110

Fax: 717-787-1873

Processing information:

  • Do not send money with this application
  • Allow 4-6 weeks for processing  

Application status

Your application will either be approved or not approved. Either way, there are next steps you will need to take: 

If Approved:

  • You will receive an approval letter via email.
  • An inspector will schedule an on-site inspection of the facility
  • Upon a compliant inspection, your registration fee will be collected, and a Food Establishment Registration issued

If not approved:

  • You will be sent a letter describing why the plans were not approved.  Applicants are encouraged to re-submit the plans again with the corrected or requested information.

If inspection is not passed:

  • You will be provided with an inspection report stating your deficiencies.  When deficiencies are corrected, you can contact your inspector to request another inspection.

Renewing license

Renewal of licenses occurs annually with notification to proprietors approximately 45 days prior to the current expiration date. Renewals can also be processed online with a user account and unique business code. You can look up your facility's business ID code on the public facility search page to proceed with online renewal.

Did you lose your license? 

Contact the department at 717-787-4315 to request a new copy of your license. 

Fees

 

Food Establishment Licenses$35
Annual renewals$35
Make checks payable to "Commonwealth of Pennsylvania"

There are only two LEGAL exemptions to the registration fee in the Food Safety Act; otherwise, all food establishments registered with PDA are subject to the registration fee of $35 renewable annually:

(1) Honey (HB2565)- A Food Establishment that is in compliance with the Act of July 20, 1974 (P.L. 537, No 184), referred to as the Honey Sale and Labeling Act, and in which 100% of the regulated products offered for human consumption are produced or processed on the farm in which the food establishment is located. Register but exempt the fee.

(2) Vehicles- Vehicles used primarily for the transportation of consumer commodities in bulk or quantity to manufacturers, packers, processors, or wholesale or retail distributors.

Contact us

Suzanne Pyle
Program Specialist
717-666-2568
supyle@pa.gov

Robert Hein
Program Specialist
717-787-5107
rhein@pa.gov