Source: https://www.agriculture.pa.gov/consumer_protection/FoodSafety/manufacturing-packing-holding-distribution/commercial-food-establishments/Pages/default.aspx
Timestamp: 2019-08-21 09:09:37
Document Index: 428613308

Matched Legal Cases: ['§5721', 'art 117', 'art 117', 'art 114', 'art 113', 'art 108']

Agriculture > Consumer Protection > Food Safety > Food Manufacturing, Packing, Holding and Distribution > Commercial Food Establishments
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.
Title 21 - Code of Federal Regulations
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:
Personnel Health and Practices
Sanitation and Controls
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:
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:
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 link below:
Click HERE for FDA Registration and Process Filing for Acidified & Low-Acid Canned Foods(LACF).
Click HERE for FDA Guidance for Processors of Acidified & Low-Acid Canned Foods.
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.
All food establishments registered with PDA are subject to registration fee of $35 renewable annually. The fee is made payable to the "Commonwealth of PA".
There are only two LEGAL exemptions to the registration fee in the Food Safety Act:
(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.
Commercial Food Manufacturers/Processors, Distributors and Warehouses:
To operate a food establishment of this type, please fill out the "Application Packet- Food Establishment Registration". This document can be found under Forms.
DO NOT SEND ANY MONEY WITH THIS APPLICATION.
Please submit your application to the appropriate Regional Office as listed on the cover letter of the Application. Please allow 4-6 weeks for processing. Once approved, you will be contacted for an on-site inspection of the establishment. Upon a compliant inspection, your registration fee of $35.00 will be collected.
Once registered with the department, a renewal application for your registration will be sent annually via USPS approximately 45 days prior to expiration of the current registration. If you have lost your current registration and need replacement or your renewal application was lost or not received, please contact a licensing clerk at 717-787-4315 for assistance.
The FDA Food Safety Modernization Act (FSMA), enacted on January 4, 2011, amended section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), in relevant part, to require that facilities engaged in manufacturing, processing, packing, or holding food for consumption in the United States register their facilities with FDA.
For more information contact FDA at 1-800-216-7331 or 301-575-0156 or visit their website here.
To access FDA guidance and regulatory information with links to Federal Register documents and other information about food safety programs, manufacturing processes, industry systems, and import/export activities, visit website here.
This information provides a cursory overview of regulatory requirements that relate to starting a food business. Click the link below to access website here.
To visit USDA/ FSIS at: USDA/FSISwebsite
USDA exempt growers/ processors, NOT under voluntary USDA inspection program, who slaughter and process poultry (1000 or fewer birds), rabbits and other non-amenable meats MUST submit an Application to register with PDA under the Food Establishment Registration program prior to starting operation.
Click HERE for more information about USDA Poultry Exemptions and other resources.
Most USDA regulations are found in Title 9 of the federal code. Click the link below to access the 9 CFR's.
Title 9 - Code of Federal Regulations
Generally, food products under the jurisdiction of USDA/FSIS include all imported and domestic meat, poultry (including food products containing 2-3% of meat and/or poultry), and processed eggs, such as liquid, frozen or dried eggs.
The Acts that give USDA/FSIS the mandate to ensure that foods under the agency jurisdiction are safe, wholesome and labeled and packed correctly are the:
Modernized GMPs Checklist
Canning for food establishment Guide
Guidance for Apple Cider and Juice Producers
Foods With Standards of Identity
Honey Processing Guideline
Rabbit - Health Guidelines
Poultry_Slaughter_Exemption_Guideline
Application Packet - Food Establishment Registration (PDF)
Deer Processor-Hunter Share the Harvest Application (PDF)
Shared Facility Agreement (PDF)