Commercial Food Establishments
Establishments
under this program would include, a building, or place or portion thereof, or
vehicle maintained, used or operated for the purpose of commercially storing,
packaging, making, cooking, mixing, processing, bottling, baking, canning,
freezing, packing or otherwise preparing or transporting or handling food.
Proprietors
intending to operate this type of food establishments must apply for a Food
Registration prior to operation. Establishments registered with the Department
can state "Reg.
Penna. Dept. of Agr." on their product
label. Only PDA registered establishments may use this
statement. Food establishments are regulated under Act 106 of 2010
(3 C.S §§5721 - 5737) which by reference incorporates all regulations in the
Code of Federal Regulations (CFR) relating to food.
Most
FDA federal regulations relating to food are found in Title 21 of the federal
code. See below for a link to the 21 CFR's. The only
exception to registration is those firms operating solely under milk or milk
product permits. Also, firms under sole jurisdiction of USDA/FSIS are
not subject to PDA registration.
Good Manufacturing Practices (GMPs) Requirements
All PA registered food establishments (no exceptions) must comply with the GMPs for Human Food Standards found in 21 CFR 117 Subpart B. GMPs are the basic operational and environmental conditions required to produce safe foods. They ensure that ingredients, products and packaging materials are handled safely and that food is manufactured, processed, held and distributed in a suitable environment and sanitary conditions. 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 help with assessing your operation's current food safety preparedness for GMPs, we recommend you use the Modernized GMPs Checklist for PA Food Establishments. The checklist is intended to serve as guidelines to help food establishments organize and document that they meet the standards.
Seafood HACCP Requirements
Seafood related food
distributors/processors must apply for a Food Registration, be inspected and
found in compliance before the Department can issue a Registration.
Seafood establishments
must meet the requirements of the Seafood HACCP regulation found in 21 CFR 123
as well as of the current Good Manufacturing Practice (GMP) requirements of 21
CFR Part 117. If required, Seafood processors must submit HACCP plan(s) for all
the products they process and or hold at the food establishment along with
their hazard analysis. If the hazard analysis reveals that there are food
safety hazards associated with their products that are reasonably likely to
occur, they must have the required HACCP plans in place for each type of fish
or fishery product they are processing/holding prior to the start of
operations.
All FDA regulations,
guidance documents and other training resources relating to Seafood HACCP can
be found on FDA website at the link below:
FDA Seafood HACCP Information
Juice HACCP Requirements
Processors
of juice and juice beverages must apply for a Food Registration, be inspected
and found in compliance before the Department can issue a Registration.
Operators
of juice or juice product wholesale businesses must meet the requirements of
the Juice HACCP regulation found in 21 CFR 120 as well as of the current Good
Manufacturing Practice (GMP) requirements of 21 CFR Part 117. If HACCP
requirements apply, processors must conduct or have conducted a hazard Analysis
and if there are food safety hazards associated with their products
that are reasonably likely to occur, they must have the required HACCP plans in
place for each type of juice or juice products they are processing prior to the
start of operations.
All FDA regulations,
guidance documents and other training resources relating to Juice HACCP can be
found on FDA website at the link below:
FDA
Juice HACCP Information
Acidified Food & LACF Requirements
Producers of Acidified Foods (AF) and Low Acid
Canned Foods (LACF) must apply for a Food Establishment Registration, be
inspected and found in compliance before the Department can issue a
Registration. Processors of these types of foods must meet the requirements of
the code of federal regulations in Part 114 for Acidified Foods and in Part 113
for thermally processed Low acid foods packaged in hermetically sealed
containers (LACF) as well as Part 108- emergency permit control for both.
Processors of acidified foods and LACF offered
for interstate commerce are also required to register with FDA, file scheduled
processes (through their process authorities), and the operation must be under
supervision of a qualified individual through education (e.g. Better Process
Control School) and/or relevant experience.
All FDA regulations, guidance documents and
other training resources relating to processing acidified and low acid foods
can be found on FDA website at the links below:
FSMA PCHF Requirements
All PDA registered food establishments will have to comply with the
applicable portions of the Food Safety Modernization Act (FSMA) rules unless
specifically exempted in the rules. 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 Warehouses:
Download and/or print, the Application Packet – Food Establishment Registration under FORMS on the right-hand side of this page.
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
- Do not send money with this application
- Allow 4-6 weeks for processing
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.
Renewal of Licenses – 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. If you do not receive a renewal application or know your business code, contact the department at 717-787-4315.
Lost/Duplicate License – Contact the department at 717-787-4315.
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.