Frequently Asked Questions - Regulations, Standards and Guidelines

Aerobic Plate Count (APC) and Standard Plant Count (SPC) microbiological levels will vary greatly between the numerous food commodities undergoing different processing methods within different processing environments. This presents a challenge to formulate a complete set of recommendations that can be conveniently applied to any food operation. Food processors must use their knowledge of the operation and the regulations, and their observations, to determine whether the establishment is in compliance.

Source: USDA Food Safety and Inspection Service

FSIS or FDA representatives should be contacted for specific questions related to the establishment, but there are electronic resources available online that may be helpful. The list of resources below serves as an information tool to facilitate a better understanding of the expectations regarding APC/SPC microbiological levels, but is not to be considered an exhaustive list of APC/SPC regulations or guidelines.

Resources containing examples of APC/SPC levels for various foods were compiled and can be found on FSRIO’s Website at Microbiological Standards and Guidelines.

In addition, please see USDA and FDA resources such as:

USDA FSIS Resources
The first two resources below are FSIS responses to questions related to APC testing, retrieved from AskFSIS, an online service that helps answer technical inspection related questions for the meat and poultry industry. The responses are then made publically available in a virtual database.

Determining APC Swab Test Limits

Addressing APC Swab Testing Programs In a Food Safety System

Questions and Answers Regarding Directives 5000.2, 6420.2, and 10,010.1,
Revision 1, and the Compliance Guidelines on E. coli O157:H7 (see page 24)

FDA Resources
Appendix 5 of the FDA & EPA Safety Levels in Regulations and Guidance
DHHS. Food and Drug Administration.
Contains a listing of FDA and EPA levels relating to safety attributes of fish and fishery products published in regulations and guidance. In many cases, these levels represent the point at or above which the agency will take legal action to remove products from the market.

ORA Laboratory Manual
DHHS. FDA. Office of Regulatory Affairs.
Training guide that introduces typical analytical procedures a regulatory microbiologist should know and understand, and shows where and how the work performed fits into the regulatory framework. See page 63 for questions and answers about FDA’s interest in APC counts.

Performance-Based Dairy Farm Inspection System
DHHS. Food and Drug Administration.
Outlines the inspection interval and criteria for Grade “A” dairy farms, including the SPC requirements for milk quality.

Laws and regulations for the sale of food prepared in home kitchens are different within each state. For example, some states simple require home kitchens to be registered with the local public health department, while others require them to be licensed and obtain a food establishment permit. Some states may even prohibit the sale of food prepared in home altogether.

To find the laws in your state visit the State Retail and Food Service Codes and Regulations available from the Food and Drug Administration.

You may also try contacting your State Department of Agriculture or an FDA Small Business Representative in your region.

To speak with an expert about the food safety laws in your state see the State and Local Contact information on FSRIO's governmental contact FAQ.

The Code of Federal Regulations defines a facility as "any establishment or structures under one ownership at one general physical location, or, in the case of a mobile facility, traveling to multiple locations, that manufactures/processes, packs, or holds food for human or animal consumption in the United States." This includes food processing or packaging plants different from a retail food business where food is serviced for an individual portion as in restaurants and retail stores.

Generally, local governments place the jurisdiction of food processing facilities under their departments of agriculture. However, be sure to contact your local heath department as well for laws and regulations specific to your state and county.

The requirements for registering your facility with the federal government depend on your food product category. Meat facilities are under the jurisdiction of the USDA and require pre-market inspection and approval before production. To register visit the USDA’s FSIS forms page and fill out the registration form: Registration of Meat and Poultry Handlers, FSIS Form 5020-1. Non-meats are under the jurisdiction of the FDA and do not require a pre-market inspection and approval before production, but still requires registration before production. To register, visit the FDA’s Food Industry Page and complete the Registration of Food Industries Step-by-Step instructions. Keep in mind that your local agriculture or health department may require pre-market inspection and approval. (Not sure if your product is under USDA jurisdiction?)

For an example business starting plan Penn State University provides Food For Profit Fact Sheets that includes information on starting up, business planning, registering your food business, insurance for food entrepreneurs, and other helpful resources.

If you would like to speak to a food safety representative regarding your product, please refer to the federal, state, and local food safety representative contacts.

A retail food business services food for an individual portion. Examples include restaurants, retail stores, and institutions. This is different from a food processing facility which is an establishment or structure(s) under one ownership at one general physical location (or in the case of a mobile facility, traveling to multiple locations), that manufactures or processes, packs, or holds food for human or animal consumption in the U.S. as defined by the FDA. Examples would include food processing or packaging plants.

Local governments are responsible for food retail business registration, legislation and enforcement. Contact your city office for local, state, and federal registration procedures for starting a business. Such procedures will address issues like setting up a proprietorship, zoning policies, and potential additional tax requirements. Contact your local health department to learn what the requirements are for obtaining a license by abiding by your state’s sanitation standards. Each state outlines these food safety standards in what is known as a food code, the majority based off of the FDA’s Food Code, which is a scientifically sound technical and legal basis for regulating the retail and food service segment of the food industry. Click here for a complete list of state food codes.

Be sure to contact your state agriculture department as well for laws and regulations that may apply to your business.
For an example business starting plan Penn State University provides Food For Profit Fact Sheets that includes information on starting up, business planning, registering your food business, insurance for food entrepreneurs, and other helpful resources.

If you would like to speak to a food safety representative regarding your product, please refer to our federal, state, and local food safety representative contacts.

The USDA (9 CFR), FDA (21 CFR), and EPA (40 CFR) are all federal regulatory entities for food safety. They each have various jurisdictions between different steps in the food distribution chain. The first step is farming, where the animal or plant is raised or harvested. The second step is processing, where the food is transformed into an edible product. The third step is transporting the food which involves import and export regulation. The final stage is retail, where the food product is serviced to consumers as an individual portion. Click here for a detailed definition for each of these terms.

Additionally, the jurisdictions vary between different food types. Meat and non-meat food products are generally divided between the USDA and FDA, respectively, but exceptions exist due to the complexity of certain food items. Click here if you are unsure about whether your product is under USDA or FDA jurisdiction. The following regulation and guideline resources are organized by the step in the food distribution chain from farm to table and then by regulations versus guidelines. The relative agencies responsible for each food category are also provided.

The resources listed below serves to assist food producers to identify where they stand in the food distribution chain and to learn where to find key regulatory information. However, if you are seeking advice for a specific question regarding your product, it is advised that you speak to a food safety representative by referring to our federal, state, and local food safety representative contacts.

If you are looking for a specific kind of regulation, try searching for it at
www.regulations.gov



Federal Regulations and Guidelines

Farming:

Laws and Regulations

Guidelines/Voluntary Programs

Environmental Protection
There are several laws set by the EPA within the Code of Federal Regulations that are related to food manufacture. These are located in 40 CFR parts 1 - 1074. Contact the Ag Center to ask an EPA representative about regulation related to your plant. It is recommended to use www.regulations.gov for updated legislation.

Processing:

Laws and Regulations

        Inspection
        The Food Safety Inspection Service (FSIS) is the agency within the USDA that ensures the safety of meat, poultry, and egg products in compliance with the Federal Meat Inspection Act, Poultry Products Inspection Act, and Egg Products Inspection Act, its authorizing statutes. Its provisions are outlined in 9 CFR Parts 300-592

        FSIS Directives
        USDA. Food Safety Inspection Service.
        Provides official communications and instruction to Agency personnel in carrying out their functions
        FSIS Notices Index
        USDA. Food Safety Inspection Service.
        FSIS Notices provide instruction in support of food safety regulations. This index consists of a completed listing of FSIS notices, organized by issue date.

        Compliance Assistance
        USDA. Food Safety Inspection Service.
        Provides information to producers and agricultural businesses to help them maintain compliance with federally defined regulations for their establishments.

              Compliance Guides Index
              Compliance guides are categorized by the following topics: E. coli, Listeria monocytongenes, Salmonella, HACCP, labeling, ready to eat products, sanitation performance standards, inspection requirements, and additional resources.

              HACCP & Pathogen Reduction Guidance Documents
              Includes a hazard identification guide, Listeria guidelines for industry, lethality and stabilization performance standards, HACCP guidelines & policies, and Standards Operating Procedures.

              Humane Interactive Knowledge Exchange
              As stated in the Federal Meat Inspection Act. The FSIS is required to enforce humane methods of handling and slaughtering of livestock to prevent needless suffering of animals.

              Labeling Guidance
              FSIS protects consumers from economically adulterated meat, poultry, and egg products by ensuring truthful labels that are not misleading.

              New Technologies
              FSIS reviews new technology that companies employ to ensure that their use is consistent with the Agency regulations and will not adversely. Includes summaries of recent technologies.

              Inspection Programs
              Under authority of the Federal Meat, Poultry and Egg Products Inspection Acts, FSIS inspects and monitors all meat, poultry and egg products sold in interstate and foreign commerce to ensure compliance with mandatory U.S. food safety standards and inspection legislation. However, establishments have the option to apply for Federal or State inspection. States operate under a cooperative agreement with FSIS. States' program must enforce requirements "at least equal to" those imposed under the Federal Meat and Poultry Products Inspection Acts. However, product produced under State inspection is limited to intrastate commerce. FSIS provides up to 50% of the State's operating funds, as well as training and other assistance.

        Shell Egg Surveillance Program
        USDA. Agricultural Marketing Service.
        AMS is responsible for shell egg surveillance inspections mandated by the Egg Products Inspection Act. The inspections enhance fair competition and facilitate marketing of consumer-grade eggs by assuring the proper disposition of “restricted eggs,” (i.e. checked and dirty eggs, leaking eggs, incubator rejects, loss and inedible eggs).

        International Maximum Residue Level Database
        USDA. Foreign Agriculture Service (FAS).

Guidelines/Voluntary Programs

Environmental Protection
There are several laws set by the EPA within the Code of Federal Regulations that are related to food manufacture. These are located in 40 CFR parts 1 - 1074. Contact the Ag Center to ask an EPA representative about regulation related to your plant. It is recommended to use www.regulations.gov for updated legislation.

Import/Export:

Laws and Regulations

        International Affairs
        USDA. Food Safety Inspection Service.
        FSIS ensures that meat, poultry, and egg products imported to the United States are produced under standards equivalent to U.S. inspection standards, and facilitates the certification of exported goods.

              Exporting Products
              Learn what requirements are necessary for exporting your products to other countries including packaging, labeling and other special conditions.

              Importing Products
              What requirements must countries meet to import product into the United States. Learn about the equivalence process, port of entry procedures, re inspection, labeling requirements, and products for personal consumption.

              Import & Export Data
              Find information to assist constituents in accessing: trade data pertinent to meat and poultry imports and exports; selected documents related to imports of meat, poultry and egg products; and links to selected Internet sites related to imports and exports of meat, poultry and egg products.

              Codex Alimentarius
              Codex activities promote the health and economic interests of consumers while encouraging fair international trade in food. The U.S. government contact point is located in FSIS.

              Commodity Analysts: Contact Information
              USDA. Foreign Agricultural Service (FAS).

              International Maximum Residue Level Database
              USDA. Foreign Agricultural Service (FAS).

Retail:

        Local governments are responsible for food retail business registration, legislation and enforcement. Contact your city office for local, state, and federal registration procedures for starting a business. Such procedures will address issues like setting up a proprietorship, zoning policies, and potential additional tax requirements. Contact your local health department to learn what the requirements are for obtaining a license by abiding by your state’s sanitation standards. Each state outlines these food safety standards in what is known as a food code, the majority based off of the FDA’s Food Code, which is a scientifically sound technical and legal basis for regulating the retail and food service segment of the food industry. Click here for a complete list of state food codes provided by the FDA.

        Be sure to contact your state agriculture department as well for laws and regulations that may apply to your business.

The Federal Trade Commission (FTC) is the regulatory entity responsible for commercial practices. As food is a commercial product, it also must adhere to all the laws outlined in under Title 16. Part 424 – Retail Food Store Advertising and Marketing Practices and Part 500 – Regulations under section 4 of the Fair packaging and Labeling are highlighted for their direct relevance to food.


State Regulations and Guidelines

In addition to Federal food safety regulations, each state has its own food laws and regulations. The list of contacts below is provided for state assistance.



Local Regulations and Guidelines

Contact your county extension agent and/or your local health department.

The USDA (9 CFR), FDA (21 CFR), and EPA (40 CFR) are all federal regulatory entities for food safety. They each have various jurisdictions between different steps in the food distribution chain. The first step is farming, where the animal or plant is raised or harvested. The second step is processing, where the food is transformed into an edible product. The third step is transporting the food which involves import and export regulation. The final stage is retail, where the food product is serviced to consumers as an individual portion. Click here for a detailed definition for each of these terms.

Additionally, the jurisdictions vary between different food types. Meat and non-meat food products are generally divided between the USDA and FDA, respectively, but exceptions exist due to the complexity of certain food items. Click here if you are unsure about whether your product is under USDA or FDA jurisdiction. The following regulation and guideline resources are organized by the step in the food distribution chain from farm to table and then by regulations versus guidelines. The relative agencies responsible for each food category are also provided.

The resources listed below serves to assist food producers to identify where they stand in the food distribution chain and to learn where to find key regulatory information. However, if you are seeking advice for a specific question regarding your product, it is advised that you speak to a food safety representative by referring to our federal, state, and local food safety representative contacts.

If you are looking for a specific kind of regulation, try searching for it at
www.regulations.gov



Federal Regulations and Guidelines

Farming:

Laws and Regulations

Guidelines/Voluntary Programs

Environmental Protection
There are several laws set by the EPA within the Code of Federal Regulations that are related to food manufacture. These are located in 40 CFR parts 1 - 1074. Contact the Ag Center to ask an EPA representative about regulation related to your plant. It is recommended to use www.regulations.gov for updated legislation.

Processing:

Laws and Regulations

        The New FDA Food Safety Modernization Act (FSMA)
        DHHS. Food and Drug Administration.
        The most sweeping reform of our food safety laws in more than 70 years, was signed into law by President Obama on January 4, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.

        Current Good Manufacturing Practices (CGMPs)
        DHHS. Food and Drug Administration.
        CGMP establishes basic legal requirements and guidance for sanitation in manufacturing, processing, packing, holding food in a food establishment, general requirements for maintenance, and minimum demands for water, plumbing design, sewage disposal, toilet and hand washing facilities. Technical reviews and the full text of 21 CFR Part 110 regarding CGMPs can be viewed here.

        Registration of Food Facilities
        DHHS. Food and Drug Administration.
        Under the Bioterrorism Preparedness and Response Act of 2002, all food facilities are required to register with the FDA. This can be performed electronically by creating an online account. Compliance information and helpful resources can be found here.

        Prior Notice of Imported Foods
        DHHS. Food and Drug Administration.
        Under the Bioterrorism Preparedness and Response Act of 2002, the FDA is to be given advance notice on shipments of imported food. This can be performed electronically by creating an online account. Other helpful resources that can be viewed here include a quick start guide, also available in Spanish.

        Compliance & Enforcement
        DHHS. Food and Drug Administration.
        Lists the Compliance Policy Guides (CPG), which explains how the FDA determines a food company’s compliance to food regulation. Its purpose is to organize statements of the FDA compliance policy. It is actively used by field inspectors in order to clarify the Agency’s standards and procedures on proper enforcement. It can also assist food businesses in preparation for inspections.

        Shell Egg Producer Registration
        DHHS. Food and Drug Administration.
        The FDA requires special registration procedures for shell egg producers in order to prevent foodborne illness caused by consumption of eggs contaminated with the Salmonella Enteritidis. The details about the regulation and online registration is available here.

        Juice HACCP
        DHHS. Food and Drug Administration.
        While HACCP is considered a voluntary food safety risk management system, juice and seafood products are mandated to follow a HACCP plan in compliance with federal register final rules, 66 FR 6137 for juice and 60 FR 665095 for seafood.

        Perishable Agricultural Commodities Act
        USDA. Agricultural Marketing Service.
        This program promotes fair trading in the fresh and frozen fruit and vegetable industry. Through PACA, buyers and sellers are required to live up to the term of their contracts and procedures are available for resolving disputes outside the civil court system.

        Federal Seed Act
        USDA. Agricultural Marketing Service.
        This act protects everyone who buys seed by prohibiting false labeling and advertising of seed in interstate commerce.

        Plant Variety Protection
        USDA. Agricultural Marketing Service.
        This program provides intellectual property rights protection to developers of new and distinct seed-reproduced and tuber-propagated plants ranging from farm crops to flowers.

        International Maximum Residue Level Database
        USDA. Foreign Agriculture Service.

Guidelines/Voluntary Programs


Import/Export:

Laws and Regulations

Retail:

        Local governments are responsible for food retail business registration, legislation and enforcement. Contact your city office for local, state, and federal registration procedures for starting a business. Such procedures will address issues like setting up a proprietorship, zoning policies, and potential additional tax requirements. Contact your local health department to learn what the requirements are for obtaining a license by abiding by your state’s sanitation standards. Each state outlines these food safety standards in what is known as a food code, the majority based off of the FDA’s Food Code, which is a scientifically sound technical and legal basis for regulating the retail and food service segment of the food industry. Click here for a complete list of state food codes provided by the FDA.

        Be sure to contact your state agriculture department as well for laws and regulations that may apply to your business.


The Federal Trade Commission (FTC) is the regulatory entity responsible for commercial practices. As food is a commercial product, it also must adhere to all the laws outlined in under Title 16. Part 424 – Retail Food Store Advertising and Marketing Practices and Part 500 – Regulations under section 4 of the Fair packaging and Labeling are highlighted for their direct relevance to food.


State Regulations and Guidelines

In addition to Federal food safety regulations, each state has its own food laws and regulations. The list of contacts below is provided for state assistance.


Local Regulations and Guidelines

Contact your county extension agent and/or your local health department.

The USDA (9 CFR), FDA (21 CFR), and EPA (40 CFR) are all federal regulatory entities for food safety. They each have various jurisdictions between different steps in the food distribution chain. The first step is farming, where the animal or plant is raised or harvested. The second step is processing, where the food is transformed into an edible product. The third step is transporting the food which involves import and export regulation. The final stage is retail, where the food product is serviced to consumers as an individual portion. Click here for a detailed definition for each of these terms.

Additionally, the jurisdictions vary between different food types. Meat and non-meat food products are generally divided between the USDA and FDA, respectively, but exceptions exist due to the complexity of certain food items. Click here if you are unsure about whether your product is under USDA or FDA jurisdiction. The following regulation and guideline resources are organized by the step in the food distribution chain from farm to table and then by regulations versus guidelines. The relative agencies responsible for each food category are also provided.

The resources listed below serves to assist food producers to identify where they stand in the food distribution chain and to learn where to find key regulatory information. However, if you are seeking advice for a specific question regarding your product, it is advised that you speak to a food safety representative by referring to our federal, state, and local food safety representative contacts.

If you are looking for a specific kind of regulation, try searching for it at
www.regulations.gov



Federal Regulations and Guidelines

Farming:

Laws and Regulations

Guidelines/Voluntary Programs

Environmental Protection
There are several laws set by the EPA within the Code of Federal Regulations that are related to food manufacture. These are located in 40 CFR parts 1 - 1074. Contact the Ag Center to ask an EPA representative about regulation related to your plant. It is recommended to use www.regulations.gov for updated legislation.


Processing:

Laws and Regulations

Guidelines/Voluntary Programs

Environmental Protection
There are several laws set by the EPA within the Code of Federal Regulations that are related to food manufacture. These are located in 40 CFR parts 1 - 1074. Contact the Ag Center to ask an EPA representative about regulation related to your plant. It is recommended to use www.regulations.gov for updated legislation.


Import/Export:

Laws and Regulations

Guidelines/Voluntary Programs

Environmental Protection
There are several laws set by the EPA within the Code of Federal Regulations that are related to food manufacture. These are located in 40 CFR parts 1 - 1074. Contact the Ag Center to ask an EPA representative about regulation related to your plant. It is recommended to use www.regulations.gov for updated legislation.


Retail:

        Local governments are responsible for food retail business registration, legislation and enforcement. Contact your city office for local, state, and federal registration procedures for starting a business. Such procedures will address issues like setting up a proprietorship, zoning policies, and potential additional tax requirements. Contact your local health department to learn what the requirements are for obtaining a license by abiding by your state’s sanitation standards. Each state outlines these food safety standards in what is known as a food code, the majority based off of the FDA’s Food Code, which is a scientifically sound technical and legal basis for regulating the retail and food service segment of the food industry. Click here for a complete list of state food codes provided by the FDA.

        Be sure to contact your state agriculture department as well for laws and regulations that may apply to your business.


The Federal Trade Commission (FTC) is the regulatory entity responsible for commercial practices. As food is a commercial product, it also must adhere to all the laws outlined in under Title 16. Part 424 – Retail Food Store Advertising and Marketing Practices and Part 500 – Regulations under section 4 of the Fair packaging and Labeling are highlighted for their direct relevance to food.


State Regulations and Guidelines

In addition to Federal food safety regulations, each state has its own food laws and regulations. The list of contacts below is provided for state assistance.


Local Regulations and Guidelines

Contact your county extension agent and/or your local health department.

GMP stands for “Good Manufacturing Practices” and GAP stands for “Good Agricultural Practices”. When applied to food safety, they are considered to be food sanitation standards. CGMPs or “Current Good Manufacturing Practices” represents the FDA’s Title 21 Part 110 in the Code of Federal Regulations which applies to food processors/facilities (not retail). Unlike CGMPs, GAP is a general term used by any entity to define “good” by their own discretion. GAPs are not enforced laws, but are still valuable guidelines for safe handling within the food industry.

All food facilities/processing plants that are under FDA jurisdiction are legally required to follow CGMPs. Meat and poultry products are not under FDA’s jurisdiction and are therefore not legally required to follow CGMPs. However, meat and poultry processing plants must adhere to the regulations of the FSIS. These include maintaining and complying with Sanitation Standard Operating Procedures (SSOP). These regulations are outlined here. (Not sure if your product is under FDA or USDA jurisdiction?)

Retail establishments are not legally required to follow CGMPs, but the general sanitation standards provided in the CGMPs can be applied.

Additional resources on CGMPs and SSOPs

Additional resources on GAPs:

To contact a food safety representative please refer to our federal, state, and local food safety representative contacts.

Food analysis involves chemical and microbiological protocols. Chemical analysis of food can detect the presence of harmful substances like pesticide residues, but it can also be used to quantify nutrient content. Microbiological analysis might be used for detecting pathogens. When applied to food safety it is essential that proper methods are used to assure that results represent the reality. To encourage the use of appropriate and accurate methods the USDA, FDA, and EPA provide test methods accessible to the public.

For current microbiological methods used by various government agencies and professional organizations, visit the FDA's Microbiological Methods web page.

The United States Department of Agriculture (USDA) Food Safety Inspection Service (FSIS) has released guidebooks that contain the current protocols for chemical, microbiological, and pathological analysis.

The Pesticide Analytical Manual (PAM) is published by the FDA as a repository of the analytical methods used in their laboratories to examine food for pesticide residues for regulatory purposes (40 CFR 180.101). The manual is organized according to the scope of the analytical methods.

While each individual country has its own food safety standards and laws, there are two international organizations that have established standards and rules to ensure consumers are being supplied with food safe to eat. They are the:

  • Codex Alimentarius Commission
  • World Trade Organization (WTO)
  • The Codex Alimentarious Commission is the body created by the FAO and WTO.

    The Commission is charged with developing the food standards, guidelines, codes of practice, and recommendations that constitute the Codex Alimentarius, or food code, which serves as a global reference point for international trade. The Codex helps to protect consumer health, ensure fair food trade practices, and coordinate food standards work undertaken by internal government and non-government organizations. The Codex is a global reference point for international food trade.

    The WTO has an international agreement on how governments can apply food safety and animal and plant health measures called the Sanitary and Phytosanitary Measures (SPS) Agreement . This agreement sets out the basic rules for food safety and animal and plant health standards, and names the joint FAO/WTO Codex Alimentarius as the relevant standard-setting organization for food safety.

    Member countries are encouraged to use the Codex international standards, guidelines and recommendations when available, but may choose to set their own standards. These standards must be science-based and "applied only to the extent necessary to protect human, animal or plant life or health".

    The Sanitary and Phytosanitary Measures (SPS) agreement has specifications for control, inspection methods, and approval procedures. Each member government must provide advance notice of new or modified sanitary and phytosanitary regulations, and establish a national enquiry point to provide information. The USDA Foreign Agricultural Service (FAS) is the U.S. Enquiry Point for all WTO member inquiries related to SPS regulations.