Food Safety Modernization Act

The FDA Food Safety Modernization Act (FSMA) is the most comprehensive reform of our federal food safety laws in over 70 years. The intent of the law is to ensure the US food supply is safe by focusing on the prevention of contamination, rather than on response to contamination.

With the release of several new rules under FSMA, it is important for New York food producers, manufacturers, distributors, importers, growers, and feed manufacturers to be informed of the content of the rules and their effective dates.

The following resources are provided to assist New York food businesses in understanding the FSMA rules and their application. Contact the Division of Food Safety and Inspection for questions regarding food and food manufacturing, and the Division of Milk Control and Dairy Services for dairy processing assistance.

The Produce Safety Rule sets forth new standards for growing, harvesting, packing, and holding of produce. The standards apply to fruits and vegetables normally consumed raw, such as apples, carrots, lettuce, onions, and tomatoes. The Produce Safety Rule does not apply to produce rarely consumed raw (such as winter squash) or produce grown for personal consumption.

The Produce Safety Rule establishes standards for:

• Agricultural water: Farmers would have to ensure that water that is intended or likely to contact produce or food-contact surfaces is safe and of adequate sanitary quality, with inspection and periodic testing requirements.
• Biological soil amendments of animal origin: The proposed rule specifies types of treatment, methods of application, and time intervals between application of certain soil amendments - including manure and composted manure and crop harvest.
• Health and hygiene: Farm personnel and visitors would have to follow hygienic practices, including hand washing, not working when sick, and maintaining personal cleanliness.
• Domesticated and wild animals: With respect to domesticated animals, the proposed rule would require certain measures, such as waiting periods between grazing and crop harvest, if there is a reasonable probability of contamination. With respect to wild animals, farmers must monitor for wildlife intrusion and not harvest produce visibly contaminated with animal feces.
• Equipment, tools, and buildings: The proposed rule sets requirements for equipment and tools that come into contact with produce, as well as for buildings and other facilities.
• Training: The proposed rule requires training for supervisors and farm personnel who handle produce covered by the rule.
• Sprouts: The proposed rule establishes separate standards for sprout production, including treatment of seed before sprouting and testing of spent irrigation water for pathogens.

Accompanying these standards are certain record-keeping requirements that document adherence to the standards, including for training, agricultural water, biological soil amendments of animal origin, and sprouts.

Are you covered?

Take our survey to help us determine whether your farm or business is covered under the Produce Safety Rule and, if so, what your compliance date is. You may also fill out our Farm Information Form to help us determine your coverage.

Resources

• Read the FDA's draft compliance and implementation guidance for the Produce Safety Rule.

• Learn about Produce Safety Rule training opportunities from Cornell University's Product Safety Alliance.

• Find information about what records are required under the Produce Safety Rule.
• Use a flowchart from the National Sustainable Agriculture Coalition to help you determine whether your farm or food business might be impacted by the FSMA rules.
• Read summaries of key requirements, compliance dates, and other information about the Produce Safety Rule from the FDA and the US Department of Health and Human Services. 
• Check out this flow chart of the FSMA final rules key dates.
• See a list of water testing labs in the northeast.
• Check out the Produce Safety Alliance's overview of cleaning and sanitizing.
• Look at a chart of compliance dates for the Produce Safety Rule.

Contact us for more information: (518) 457-3846.

The Preventive Controls for Human Food (PCHF) Rule sets forth new requirements and updates existing requirements for facilities that manufacture, process, pack, or hold human food.

Requirements

Facilities that are subject to the full requirements of PCHF must establish and implement a food safety system that includes an analysis of hazards and risk-based preventive controls. This food safety system includes a written food safety plan that includes the following elements:

• Hazard analysis: What are the known or reasonably foreseeable biological, chemical, and physical hazards that occur naturally, are unintentionally introduced, or are intentionally introduced, that could affect the safety of the food.
• Preventive controls: Measures that are required to minimize or prevent the identified hazards, including:
  • Process controls: procedures, practices, and processes to control parameters during operations. Examples of process controls are cooking and refrigeration, and product formulation.
  • Food allergen controls: procedures, practices, and processes to control allergen cross-contact within a facility and procedures to ensure all food allergens are correctly labeled.
  • Sanitation controls: procedures, practices, and processes to make sure the facility is maintained in a sanitary manner to control hazards such as environmental pathogens. Environmental monitoring is required if contamination of a ready-to-eat food with an environmental pathogen such as Listeria monocytogenes is a hazard requiring a preventive control.
  • Supplier-chain controls: a risk-based approach to ensure suppliers are not providing food establishments with raw materials or ingredients that pose a significant risk to the final product made by the firm.
  • Other appropriate controls: preventive control procedures that are not process, food allergen, or sanitation controls, but are necessary to ensure that a hazard requiring a preventive control will be significantly minimized or prevented.
• Oversight and management of preventive controls:
  • Monitoring: These procedures are designed to provide assurance that preventive controls are consistently performed. Monitoring is conducted as appropriate to the preventive control. For example, monitoring of a heat process to kill pathogens would include recording temperature values. Monitoring must be documented.
  • Corrections: These are steps taken, in a timely manner, to identify and correct a minor, isolated problem that occurs during food production.
  • Corrective actions: These include actions to identify and correct a problem implementing a preventive control, reduce the likelihood the problem will recur, evaluate affected food for safety, and prevent that food from entering commerce if you cannot ensure that the affected food is not adulterated. Corrective actions must be documented with records.
  • Verification: These activities are required to ensure that preventive controls are consistently implemented and effective in minimizing hazards. Examples of verification activities include scientifically validating process preventive controls to ensure that the control measure is capable of effectively controlling an identified hazard and calibrating (or checking the accuracy of) process monitoring and verification instruments such as thermometers. Verification activities also include reviewing records to ensure that monitoring and corrective actions (if necessary) are being conducted. Verification activities must be documented.
    • Product testing and environmental monitoring are also possible verification activities, required as appropriate to the food, facility, nature of the preventive control, and the role of that control in the facility’s food safety system. Environmental monitoring is required if the contamination of a ready-to-eat food with an environmental pathogen is a hazard the facility identified as requiring a preventive control.
• Record-keeping: Documentation of compliance with the written food safety plan to include but not limited to monitoring, corrective actions, corrections, and verification activities. Required records shall be made available to the regulatory authority (New York State and/or FDA).
• Recall Plan: If the hazard analysis identifies a hazard that requires a preventive control, you must have a written recall plan that includes the procedures that describe the steps to perform the recall and at minimum assigns responsibility for: 
  • notifying the direct consignees of the food being recalled, including how to return or dispose of the affected food;
  • notifying the public about hazards in the food;
  • conducting effectiveness checks; and
  • disposing of the recalled product in an appropriate way.

Learn how to develop a food safety plan with the FDA's Food Safety Plan Builder.

Please note: Only an individual qualified either through training or experience can write a facility’s food safety plan. Food safety plans will be reassessed every three years, or more frequently if there are problems. 

Exemptions

Establishments that are exempt from PCHF 21 CFR 117 Subparts C, G, and D include:

• Food establishments covered by separate regulations including juice, seafood, dietary supplements, alcoholic beverages, or Low-acid canned foods (for C. botulinum control only as regulated by Part 113)

• Establishments such as grain elevators and warehouses that are solely engaged in storing agricultural commodities (other than fruits and vegetables) intended for further processing

• Establishments, such as warehouses, that only store packaged foods that are not exposed to the environment and for which refrigeration is not required for safety
• Establishments that are small or very small on-farm businesses that conduct certain low-risk manufacturing and processing, packing, or holding activities (e.g., making jams/jellies, honey, maple syrup, candy, soft drinks, etc.)

A farm is not covered by the new requirements unless it is a mixed-type facility which is an establishment that is a farm, but also conducts activities outside the farm definition that require the establishment to be registered as required under section 415 of the Federal FD&C Act. 

Modified Requirements and Qualified Facilities

Facilities that are defined as very small or are qualified (21 CFR Part 117.5(a)) are considered qualified facilities. Such facilities are subject to the modified requirements provided in 21 CFR 201 and are not subject to Preventive Controls 21 CFR 117 - Subparts C and G.

A facility is subject to modified requirements if:

1. it is defined as a very small business (21 CFR 117.3), or
2. the average annual monetary value of all food sold during the last 3 years was less than $500,000 and sales to qualified end-users exceeds sales to others.

Learn more about whether you are a qualified facility.

Qualified facilities must file a qualified facility attestation with FDA.

Requirements for Warehouse and Storage Facilities

These establishments are solely engaged in the storage of refrigerated unexposed packaged foods when temperature controls are necessary to prevent pathogen growth. These firms must: 

1. establish and implement temperature controls adequate to significantly minimize or prevent pathogen growth and toxin formation,

2. monitor the temperature controls at adequate frequency,
3. take appropriate corrective actions when there is loss of temperature control,
4. verify temperature controls, and
5. establish and maintain records.

See the complete requirements in 21 CFR 117.206.

Please note: Warehouse and distribution establishments engaged in the storage of any exposed food products or engaged in any processing or manufacturing activities or “value added services” (e.g. blast freezing, roasting, tempering, labeling, repacking) may be subject to the PCHF rule requirements where they need to conduct a hazard analysis and may need to implement preventive controls.

Updated GMP Requirements

The PCHF rule also updates current Good Manufacturing Practice (cGMP) requirements. All facilities, including those that are exempt or subject to modified requirements in the new requirements for hazard analysis and preventive controls are subject to cGMP requirements.

The new updates include requirements for:

• Training
  • Management is required to ensure that all employees who manufacture, process, pack, or hold food are qualified to perform their assigned duties. The employees must be trained in the principles of food hygiene and food safety, including the importance of employee health and hygiene as appropriate to the food, the facility, and the individual’s assigned duties. Records of training must be maintained.
• Control of allergen cross-contact
  • Allergen cross-contact is now explicit in the regulatory text. Facilities are required to employ practices and procedures to control allergen cross-contact.
• Human food by-products used for animal foods
  • The updated CGMPs contain provisions for holding and distributing human food by-products that are used for animal food.

Training

The PCHF rule requires a facility to identify a person deemed by the facility to be a preventive controls qualified individual (PCQI). The individual must have successfully completed PCQI training in the development and application of risk-based preventive controls under a FDA standardized curriculum. Get more information on Preventive Control Qualified Individual (PCQI) Training, including class times and registration.

Resources

• Read the FDA's draft guidance to minimize food safety hazards of fresh-cut produce.

• View Cornell College of Agriculture and Life Sciences' FSMA resources, including information about training opportunities.

• Read summaries of key requirements, compliance dates, and other information about Preventive Controls for Human Food from the FDA and the US Department of Health and Human Services.
• Check out this flow chart of the FSMA final rules key dates.
• Explore the Processors’ Food Safety Toolkit from the Northeast Center to Advance Food Safety.

Food facility registration helps FDA determine the location and source of potential bioterrorism or foodborne illness outbreak incidents, and also helps the agency quickly notify facilities that may be affected. Food facility registration requirements were initially brought about by The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with FDA. FSMA then amended the FD&C Act to require domestic and foreign facilities to submit certain additional new information to FDA and to renew registrations every other year. In 2016, FDA issued a final rule updating FDA’s registration regulation, including to reflect the FSMA amendments.

Learn more

Register your facility

With the release of several new rules under FSMA, it is important for New York food producers, manufacturers, distributors, importers, and feed manufacturers to be informed of the content of the rules and their effective dates.

The following resources are provided to assist New York animal feed and pet food businesses in understanding the FSMA Preventive Controls for Animal Food Rule and their application to animal feed/food and pet food.

Below are the key requirements and conclusions from the Animal Foods Preventive Controls Rule:

• Current GMP standards
  • The FDA has finalized baseline current Good Manufacturing Practice (cGMP) standards for producing safe animal food that take into consideration the unique aspects of the animal food industry and provide flexibility for the wide diversity in types of animal food facilities.
  • Processors already implementing human food safety requirements, such as brewers, do not need to implement additional preventive controls or cGMP regulations when supplying a by-product (e.g., wet spent grains, fruit or vegetable peels, liquid whey) for animal food, except to prevent physical and chemical contamination when holding and distributing the by-product. Examples of physical and chemical contamination include placing trash or cleaning chemicals into the container holding the by-products. This regulation applies to human food facilities that donate or sell a by-product for use as animal food. Further processing a by-product for use as animal food (e.g., drying, pelleting, heat-treatment) requires companies to process the by-product in compliance with cGMPs to ensure the animal food’s safety and to make sure that the processing does not introduce hazards to the animal food. The company can choose to follow either the human food or animal food cGMPs when further processing the by-product.
  • In addition, unless it is a qualified facility or otherwise exempt from subpart C (hazard analysis and preventive controls), the facility needs to assess its process and determine whether there are any hazards that would require a preventive control.
  • A facility that determines through its hazard analysis that there are no hazards requiring a preventive control would document such a determination in its hazard analysis but would not need to establish preventive controls.
• Food safety system and food safety plan
  • Covered facilities must establish and implement a food safety system that includes an analysis of hazards and risk-based preventive controls. The rule sets requirements for a written food safety plan that includes:
    • Hazard analysis: The plan must identify and evaluate hazards for each type of food manufactured, processed, packed, or held at the facility.
    • Preventive controls: The plan must identify preventive controls that significantly minimize or prevent hazards. Preventive controls include process controls, food allergen controls, sanitation controls, and a recall plan.
    • Oversight and management of preventive controls: The final rule provides flexibility in the steps needed to ensure that preventive controls are effective and to correct problems that may arise.
    • Monitoring: These procedures are designed to provide assurance that preventive controls are consistently performed. Monitoring is conducted as appropriate to the preventive control. For example, proper refrigeration could be documented with either affirmative records demonstrating temperature is controlled or “exception records” demonstrating loss of temperature control.
    • Verification: These activities are required to ensure that preventive controls are consistently implemented and effective. They include validating with scientific evidence that the control is capable of effectively controlling an identified hazard; confirming implementation and effectiveness; and verifying that monitoring and corrective actions (if necessary) are being conducted. Product testing and environmental monitoring are possible verification activities but are only required as appropriate to the food, facility, nature of the preventive control, and the role of that control in the facility’s food safety system.
    • Corrective actions and corrections: Corrections are steps taken to timely identify and correct a minor, isolated problem that occurs during animal food production. Corrective actions include actions to identify a problem with preventive control implementation, to reduce the likelihood the problem will recur, to evaluate affected animal food for safety, and to prevent it from entering commerce. Corrective actions must be documented with records.
    • Recall plan: Every facility that produces animal food with a hazard requiring a preventive control must have a recall plan.
• Risk-based supply chain program requirements
  • The rule mandates that an animal food manufacturing/processing facility have a risk-based supply chain program for those raw materials and other ingredients for which it has identified a hazard requiring a supply-chain-applied control. Animal food facilities that control a hazard using preventive controls, or that follow requirements applicable when relying on a customer to controls hazards, do not need to have a supply-chain program for that hazard.
  • Animal food facilities are responsible for ensuring that raw materials and other ingredients with a supply-chain-applied control are received only from approved suppliers, or on a temporary basis from unapproved suppliers whose raw materials or other ingredients are subject to verification activities before being accepted for use. (Approved suppliers are those approved by the facility after a consideration of factors that include a hazard analysis of the food, the entity that will be controlling that hazard, and supplier performance.) A facility will not be required to implement a preventive control when an identified hazard will be controlled by another entity in the distribution chain, such as a customer or other processor. The receiving facility will have to disclose that the food is “not processed to control (identified hazard)” and obtain written assurance from its customer regarding certain actions that customer agrees to take.
  • Separate compliance dates have been established for the supply-chain program provisions so that a food facility will not be required to comply with the supply-chain program provisions before its supplier is required to comply with the preventive controls for animal food rule or the produce safety rule.
• Clarified farm definition
  • The definition of a ‘farm’ is clarified in the Preventive Controls for Human Food final rule to cover two types of farm operations. Operations meeting the definition of a ‘farm’ are not subject to the Preventive Controls for Animal Food rule.
    • Primary Production Farm: This is an operation under one management in one general, but not necessarily contiguous, location devoted to the growing of crops, the harvesting of crops, the raising of animals (including seafood), or any combination of these activities.
    • Secondary Activities Farm: This is an operation not located on the Primary Production Farm that is devoted to harvesting, packing, and/or holding raw agricultural commodities. It must be majority owned by the Primary Production Farm that supplies the majority of the raw agricultural commodities that are harvested, packed, or held by the Secondary Activities Farm. The secondary activities farm definition has very limited application to animal food beyond the packing and holding of grain.
• Further defining feed mills associated with farms
  • Feed mills associated with fully vertically integrated farming operations (i.e., farms where the feed mill, animals, land, and establishment are all owned by the same entity) generally meet the definition of a farm and are therefore not subject to the Preventive Controls for Animal Food final rule.
  • The FDA remains concerned that not having these operations subject to the Preventive Controls for Animal Food final rule leaves a gap in the protection of human and animal health because these feed mill operations manufacture significant amounts of animal food.
  • The FDA intends to publish a proposed rule in the future that would require some feed mill operations that currently are part of a farm to implement the current good manufacturing practices established by the Preventive Controls for Animal Food rule.

Resources

• Read summaries of key requirements, compliance dates, and other information about Preventive Controls for Animal Food from the FDA and the US Department of Health and Human Services.

• Learn about training opportunities and other resources from the Association of American Feed Control Officials.

• Look at the FDA'S resources for the Preventive Controls for Animal Food rule.
• Get FSMA Technical Assistance.
• Check out this flow chart of the FSMA final rules key dates.

The FDA adopted a regulation on foreign supplier verification programs (FSVPs) for importers of food for humans and animals. The regulation requires importers to verify that food they import into the United States is produced in compliance with the hazard analysis and risk-based preventive controls and standards for produce safety provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), is not adulterated, and is not misbranded with respect to food allergen labeling. FDA issued this regulation in accordance with FSMA. The regulation will help ensure the safety of imported food.

Resources

• Read summaries of key requirements, compliance dates, and other information about the FSVP from the FDA and the US Department of Health and Human Services. 

• Use this flowchart to find out whether you are subject to FSVP.

• Visit FDA's website to read the FSMA rule on FSVP, and to find additional resources.
• Check out this flow chart of the FSMA final rules key dates.