Frequently Asked Questions

Current Research and Literature

Contacts and Experts

Federal Contact Information

The USDA, FDA, EPA, and CDC are the U.S. government agencies that regulate food safety.

United States Department of Agriculture (USDA)
Protects and promotes food, agriculture, natural resources and related issues. The department is responsible for the safety of meat, poultry and eggs. (Not sure if your product is under USDA jurisdiction?)

Contact Us
Call the information hot line or view the available directories. You can also search for your question in the USDA’s online knowledgebase.

USDA County Service Centers
Single locations where customers can access the services provided by the Farm Service Agency, Natural Resources Conservation Service, and the Rural Development agencies.

          Food Safety Inspection Service
          Agency responsible for ensuring that the nation’s commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged.

          AskFSIS
          Web-based application designed to help answer technical and policy-related questions from inspection program personnel, industry, consumer groups, other stakeholders, and the public.

          Electronic Mailboxes Available
          Lists the electronic mailing addresses of the contact services provided by the FSIS.

          Key Agency Contacts
          Officers listed by FSIS program located at headquarters in Washington D.C.

          Office Locations & Phone Numbers
          Contact your state FSIS field office for specific inspection questions.

          State HACCP Contacts & Coordinators
          Provides technical advice, assistance, resources, and conduct activities to support HACCP implementation and small and very small plants.

          Policy Development Division
          For technical service support

          USDA Meat and Poultry Hot line
          Toll-free telephone and email service staffed by food safety specialists for consumer food safety questions. Extends service to Spanish speakers as well. Receives and responds to more than 80,000 calls yearly.

          Animal and Plant Health Inspection Service (APHIS)
          Agency responsible for protecting and promoting U.S. agricultural health, regulating genetically engineered organisms, administering the Animal Welfare Act and carrying out wildlife damage management activities.

          Program and Office ContactsOffice phone and email contact information listed by program such as Animal Care and Emergency Management Safety & Security Division.

          Foreign Agriculture Service (FAS)
          Represents U.S. agriculture abroad, coordinates international trade policy, analyzes production and trade, promotes and assists U.S. agriculture, provides commercial financing support to U.S. exporters, and collaborates with other countries to facilitate trade and promote security.

          Contact Us
          Provides phone and email contact information for officers and subject experts.
          Agency responsible for developing quality grade standards for agricultural commodities, administering marketing regulatory programs, marketing agreements and orders, and making food purchases for USDA food assistance programs such as the National Organic Program.

          Contact Us
          Email the agency administrator for specific questions or email the agency webmaster to learn how to find something.

          AMS Key Agency Program Contacts
          Phone and email contact information for program administrators.


Food and Drug Administration (FDA)
Responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The administration regulates non-meat products including seafood, produce, milk, canned foods, and infant formula. (Not sure if your product is under FDA jurisdiction?)

Small Business Representatives
Provides technical assistance for small businesses. Organized by region and state.

          Center for Food Safety and Applied Nutrition (CFSAN)
          Responsible for promoting and protecting the public’s health by ensuring that the nation’s food supply is safe, sanitary, wholesome, and honestly labeled, and that cosmetic products are safe and properly labeled.

          Contact CFSAN
          Toll-free information phone and email hot line for industry and consumer questions.

          Center for Veterinary Medicine (CVM)
          Regulates the manufacture and distribution of food additives and drugs that will be given to animals. These include animals from which human foods are derived, as well as food additives and drugs for pet (or companion) animals. CVM is responsible for regulating drugs, devices, and food additives given to, or used on, over one hundred million companion animals, plus millions of poultry, cattle, swine, and minor animal species.

          Contact Us
          Observe the right panel for telephone number and email of the Communications Staff.


Environmental Protection Agency (EPA)
Responsible for protecting human health and to safeguard the natural environment – air, water and land – upon which life depends. Regulates pesticides and waste management.

Contact the Ag Center
Contains the contacts of National Agriculture Compliance Assistance Center, the Office of Compliance, and the Agriculture Division.


Center for Disease Control and Prevention (CDC)
Responsible for creating the expertise, information, and tools that people and communities need to protect their health – through health promotion, prevention of disease, injury and disability, and preparedness for new health threats. This includes providing food recall information.

Contact CDC
Directs you to the center that can most appropriately answer your question. Telephone service information is located at the bottom of the page. Includes a commonly asked questions index organized alphabetically.



State Contact Information

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 Contact Information

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

          Local Health Departments
          Contains links to almost 1,200 local health departments. Listed by state.

          Cooperative Extension System Offices
          USDA provides an interactive map that enables one to locate their nearest extension office which is staffed by a food safety expert to assist producers, small business owners, and consumers.

There are a few ways to get in contact with a food scientist to visit your classroom. The Institute of Food Technologists (IFT) provides membership benefits, networking opportunities, education, lobbying activities, and more for the food industry to advance the science of food around the world. Check to see if your state has a local regional chapter and contact an appropriate officer.

You can also try contacting your cooperative extension agent.

There are several different independent food testing laboratories, each providing different microbiological, chemical, and/or physical hazard tests. The resources below contain comprehensive lists of accredited food testing laboratories.

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.

    Grading, Certification, and Inspection

    The Agricultural Marketing Service (AMS) has several auditing programs to provide producers and suppliers of agricultural products including produce, and livestock, and poultry, the opportunity to assure customers of their ability to provide consistent quality products or services. AMS utilizes ISO and HACCP guidelines to train their auditors to evaluate program documentation, to ensure consistent auditing practices, and to promote international recognition of audit results.

    Grading Certification and Verification
    USDA. Agricultural Marketing Service.

    Other third party audits include:

    The National Organic Program is operated by the USDA's Agricultural Marketing Service. To apply, contact your local accredited certifying agency.

    HACCP

    HACCP is mandatory by law for manufacturers of meat and poultry, seafood, and juice products. It is otherwise voluntary, provided that the food plant implements a written preventive controls plan according to the Food Safety Modernization Act.

    While it is not mandatory to implement HACCP for other types of food, its use is widely encouraged. Thus, researchers publish numerous guidance documents that explain the principles of HACCP and contain complete HACCP Plans, flow charts, and hazard analysis worksheets.

    FSRIO provides HACCP Resources mentioned above along with SOP templates, and related regulatory information. Observe the right navigation panel for specific resources on Food Service, Juice, Seafood, and Meat & Poultry HACCP.

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    FSRIO provides HACCP resources including examples of HACCP hazard analysis worksheets, HACCP plans, and flow charts for different product categories as well as template SOPs, and related regulatory information. Observe the right navigation panel for specific resources on Food Service, Juice, Seafood, and Meat & Poultry HACCP.

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    The International HACCP Alliance was developed to provide a uniform program to assure safer meat and poultry products. Their website posts several upcoming training activities, including introductory and advanced HACCP courses by accredited training programs. To find a training course nearby, search for a training session being held at a location nearest to you and on a date you are able to attend. The training activities page also provides the list of accredited course providers’ contact information, alliance approved curriculums, and education materials.

    The Seafood Network Information Center provides upcoming trainings specifically for seafood HACCP.

    To find a meat and poultry HACCP course, you may also try contacting your State HACCP Contact or Coordinator.

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    Import / Export

    Import and export policies vary based on the effective nation. The Codex Alimentarius offers a searchable database of current official standards and guidelines of import/export policies. You can search here for standards on your export food product to determine if your standards comply with international standards.

    For import and export assistance contact the United States Foreign Agricultural Service:

    United States Importing/Exporting

    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.

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    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.

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    More than 12 federal agencies regulate food safety in the United States. However, four agencies play a major role in monitoring imports: the Food Safety and Inspection Service (FSIS), the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), and the Department of Commerce’s National Marine Fisheries Service (NMFS).

  • Food Safety and Inspection Service
  • Food and Drug Administration
  • Environmental Protection Agency
  • National Marine Fisheries Service
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    Many countries worldwide have different regulations based on their own food safety standards. The differences among these countries can potentially affect international trade relations. A report titled, International Trade and Food Safety: Economic Theory and Case Studies by the USDA Economic Research Service presents research on the interaction between food safety and international trade.

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    U.S. imports of fish and seafood products must meet the same requirements as domestic product. The regulations are under the Safe and Sanitary Processing and Importing of Fish and Fishery Products (21 CFR part 123) and require that all seafood products in interstate commerce in the U.S. must have been processed in accordance with the FDA Seafood HACCP regulations.

    The FDA has provided Web sites from several countries that have Lists of Foreign Processors Approved by their Governments.

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    There are two different Export Certificate Lists. In the past, the EU used the FDA List of Approved Seafood Processors for acceptance of US seafood shipments. Due to a change in EU legislation, they now maintain their own Official EU List.

    For details, please read the FDA's announcement to all shippers.

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    Jobs and Professional Development

    The National Restaurant Association Educational Foundation (NRAEF) provides information on ServSafe training for managers and food handlers.

    The American National Standards Institute (ANSI) currently has food protection manager certifications that meet the Conference for Food Protection (CFP) standards. These certifications are listed on the ANSI Web site. Each of these certification bodies have Web sites that will allow you to locate a test site or provider in your area:

    Since each state, county, or city jurisdiction decides which, if any, of these certification(s) is required, please check with your local health department or the ServSafe – Manager Regulatory Map to determine which are approved.

    The Education and Training Materials Database available at the Food Safety Research Information Office allows users to search for materials based on many different languages such as Vietnamese, Chinese, Russian, Spanish, Portuguese, and many more.

    The Food Safety Education and Training Materials Database includes computer software, audiovisuals, posters, games and teaching guides for elementary and secondary school education; training materials for the management and workers of retail food markets, food service establishments and institutions; educational research and more. It also includes materials from many different languages.

    Hand washing posters, training kits, CD-ROMS, video cassettes, curriculum, and other materials can be found on the Food Safety Education and Training Materials Database

    Additional hand washing materials are available from the following organizations:

  • AIB Food Safety Poster Archive
  • Massachusetts Department of Public Health
  • National Food Service Management Institute
  • Pathogens and Contaminants

    The USDA provides the Predictive Microbiology Information Portal to assist food companies in the use of predictive models. This portal contains the Pathogen Modeling Program a package of models that predicts the growth and inactivation of foodborne bacteria under variable environmental conditions. The PMIP also contains, ComBase, a database of quantitative microbiological or kinetic data collected from different laboratories. Users can narrow their searches by food type, organism, temperature, pH, water activity, and NaCl. These tools can be used for estimating the effects of multiple variables on the growth, survival and inactivation of food borne pathogens.

    The FDA's Foodborne Pathogenic Microorganisms and Natural Toxins Handbook (Bad Bug Book) includes a description of each food pathogen and its associated foodborne illness. Information includes acute symptoms, diagnosis, onset time, associated foods, outbreaks, disease complications and incidence. The following chart provides a summary of Typical Onset, Duration, and Symptoms of Foodborne Illnesses.

    The CDC also provides information about foodborne diseases and outbreaks. According to the CDC, about 76 million Americans get sick, more than 300,000 are hospitalized, and 5,000 people die from foodborne illnesses each year. For more information on foodborne illness statistics, visit FoodNet - Foodborne Diseases Active Surveillance Network.

    Acrylamide is a chemical contaminant in food caused by a chemical reaction that occurs when foods are fried, deep-fried or oven-baked. Find more information on acrylamide in food at:

    The Pathogen Modeling Program is used to predict the growth and inactivation of foodborne pathogens under certain conditions. Please visit the PMIP for information on the Pathogen Modeling Program.

    The USDA's Animal and Plant Health Inspection Service (APHIS) and USDA's Food Safety Inspection Service (FSIS) closely monitor BSE-related issues in the United States.

    For current information, please visit their BSE web pages:

  • APHIS
  • FSIS

    FSRIO also provides Additional Resources.

  • Food Technology

    The USDA, the FDA, and the EPA all have a role in regulating agricultural biotechnology in the United States.


    USDA
    The Animal and Plant Health Inspection Service (APHIS) of the USDA is responsible for protecting American agriculture against pests and diseases. The agency regulates the field testing of genetically engineered plants and certain microorganisms.


    FDA
    The FDA is responsible for the safety and proper labeling of all plant-derived, genetically engineered food and feed. Under the Federal Food, Drug, and Cosmetic Act, the FDA ensures that food and feed manufacturers meet regulations and standards.


    EPA
    The EPA regulates the sale, distribution, and use of all pesticides in the environment, including those that are produced by an organism through techniques of modern biotechnology. The EPA also sets tolerance limits for residues of pesticides on and in food and animal feed.


    For more information visit the United States Regulatory Agencies Unified Biotechnology Web site.

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    There are a variety of sanitizing agents that have been shown to pathogenic growth on fresh produce. The FDA's Center for Food Safety and Applied Nutrition report: Analysis and Evaluation of Preventive Control Measures for the Control and Reduction/Elimination of Microbial Hazards on Fresh and Fresh-Cut Produce describes various methods and sanitizing agents used in reducing pathogens on produce.

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    Food irradiation is a cold process that uses ionizing radiation to kill microorganisms without affecting the temperature. The irradiation process can also extend the shelf life of foods by destroying or inactivating spoilage microorganisms and ripening enzymes.

    The Food Safety Project of the Iowa State University Extension provides a fact sheet on food irradiation.

    In addition, find Food Irradiation Resources on the FSRIO Web site:

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    Biosensor technology is used for the rapid detection of pathogens in our food supply. Since food pathogens can be a serious threat to public health, much research is being completed to reduce the risk of foodborne illness.

    Biosensor research projects conducted by the USDA and other agencies can be viewed at the FSRIO Research Projects Database.

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    Food Preparation, Handling, and Storage

    Food preparation, handling and storage information is available at:

    Kitchen Companion
    USDA. Food Safety and Inspection Service.

    Food Storage Guide
    North Dakota State University.

    Food Keeper
    Food Marketing Institute.

    Safe Food Handling and Preparation Fact Sheets
    USDA. Food Safety and Inspection Service.

    Food preparation and Handling
    Food Safety Research Information Office (FSRIO)

    The FSIS provides the cooking temperature requirements for meat, poultry, and fish. They also provide the temperatures for safe storage of these foods.

    For consumer food safety questions contact the USDA Meat and Poultry Hotline. It is a toll-free telephone and email service staffed by food safety specialists. Receives and responds to more than 80,000 calls yearly. Extends service to Spanish speakers as well.

    The USDA Meat and Poultry Hotline offers the following recommendations for sending food gifts to U.S armed service members overseas:

    • Dried beef or poultry such as beef jerky, turkey jerky or beef slims are safe to mail. Bacteria can’t grow in foods preserved by removing moisture.
    • Dehydrated soups and drink mixes are lightweight and safe to mail. Condiments such as hot sauce and Cajun seasonings in packets or unbreakable jars are useful for spice lovers.
    • Canned specialties such as corned beef, anchovies, shrimp, dips and cracker spreads make nice treats. Recipients should be cautioned not to use any cans that are damaged or swollen. Foods in glass containers should not be mailed because they can break.
    • Dense and dry baked goods such as fruit cakes and biscotti are good choices for mailing because they will not mold. Other suitable baked goods include commercially packaged cakes and cookies in airtight tins, dry cookies such as ginger snaps and specialty crackers.
    • High-moisture baked goods such as pumpkin bread -- while safe at room temperature for a few days -- should not be mailed because they will most likely mold before delivery. Fragile foods like delicate cookies won’t make the trip intact. When mailing firm cookies and homemade candies, wrap each piece individually and pack items in commercially popped corn, Styrofoam packing "peanuts" or foam to help cushion the trip. Place the food gifts in a sturdy box and seal it securely with packing tape.
    • Dried fruits such as raisins and apricots, canned nuts and fruit and commercially packaged trail mix need no refrigeration.
    • Hard candies and sturdy homemade sweets such as pralines and toffee are safe to mail because their high sugar content prevents bacterial growth.

    As an alternative to homemade gifts, some families may wish to send a military member’s favorite mail order foods. Shelf stable beef “summer sausage,” cheeses, cakes and snacks can be ordered on the Internet or through mail order catalogues. Because of the delivery time and distances between the U.S. and duty stations overseas, do not order any food gifts that must be kept refrigerated for safety.

    For additional information please see the following resources:

    There are several sites which provide information to truckers involved in food transport. The Agricultural and Food Transporters Conference held by the American Trucking Associations provides a unique opportunity to speak with industry professionals and experienced food transporters.

    Listed below are additional sources for food transport safety:

    Food Recalls / Product Complaints

    If you would like to make a complaint about a food product and/or report a food poisoning, the problem should be reported to the appropriate government agency. Both reporting types are explained below.

    REPORT FOOD POISONING

        • If you think you have food poisoning or an allergic reaction to food, call your doctor. If it’s an emergency, call 911.
        • If you believe you or someone you know became ill from eating a certain food, contact your local health department AND contact the appropriate government agency to report the food as explained below.
        • Reporting illnesses to your local health department helps them identify potential outbreaks of foodborne disease.
        • For more information on how public health officials investigate foodborne outbreaks, see A Step-by-Step Guide to Investigating Foodborne Outbreaks.



    REPORT A PROBLEM WITH FOOD
    There are different government agencies that are responsible for protecting food depending on the type of food and if the food was consumed at home or at a restaurant. For an overview of how to report a problem with food, follow these guidelines:

    Meat, Poultry, and Egg Products - United States Department of Agriculture (USDA)
    To report a problem with meat, poultry, and egg products, call the toll-free USDA Meat and Poultry Hotline at 1-888-MPHotline (1-888-674-6854) or report the complaint on line at the Electronic Consumer Complaint Reporting Form.

          For more details about reporting a problem to the USDA see these resource below:

          In order for the USDA to investigate a problem with meat, poultry or egg products, you must have:

              1. The original container or packaging
              2. Any foreign object that you might have discovered in the product
              3. Any uneaten portion of the food (refrigerate or freeze it)

          Information you should be ready to tell the Hotline on the phone includes:

              1. Name, address and phone number
              2. Brand name, product name and manufacturer of the product
              3. The size and package type
              4. Can or package codes (not UPC bar codes) and dates
              5. Establishment number (EST) usually found in the circle or shield near the "USDA passed and inspected" phrase
              6. Name and location of the store, as well as the date that you purchased the product
              7. You can complain to the store or the product's manufacturer if you don't choose to make a formal complaint to the USDA.

    Non-Meat Food Products (Cereals, Fish, Produce, Fruit Juice, Pastas, Cheeses, etc) Food and Drug Administration (FDA)
    To report non-emergencies about food (except for meat, poultry or egg products), contact the district office consumer complaint coordinator assigned to your geographic region. If you or someone you are with is currently having a non-life threatening adverse reaction to an FDA-regulated product that requires immediate reporting, call the Food and Drug Administration Main Emergency Number (1-866-300-4374). If you are experiencing a medical emergency, please call 911.

          What should I include in my report?

              • Report what happened as soon as possible. Give names, addresses and phone numbers of persons affected. Include your name, address and phone number, as well as that of the doctor or hospital if emergency treatment was provided.
              • State the problem clearly. Describe the product as completely as possible, including any codes or identifying marks on the label or container. Give the name and address of the store where the product was purchased and the date of purchase.
              • You also should report the problem to the manufacturer or distributor shown on the label and to the store where you purchased the product.

    Restaurant Food
    To report a problem with restaurant food, call your local health department. You may also try contacting your state health department.

    For information on food recalls from both the USDA and the FDA visit www.recalls.gov.