Food Safety Modernization Act

Food Safety Modernization Act (FSMA)

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 U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.

With the release of several new rules under the Food Safety Modernization Act, it is important for Vermont 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 Vermont food businesses in understanding the FSMA rules and their application. The Agency of Agriculture, Food & Markets is also available to answer questions at (802) 522-3132.

General FSMA Information

FSMA Fact Sheets and Presentations

FSMA Resources

FSMA FAQs

FSMA Technical Assistance

 

Produce Safety Rule

OVERVIEW: 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 proposed Produce 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 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 recordkeeping requirements that document adherence to the standards, including for training, agricultural water, biological soil amendments of animal origin, and sprouts

AT A GLANCE: For a quick overview of the Produce Safety Rule requirements click on the link below:

Produce Safety Rule ‘at a Glance’

Produce Coverage Flowchart

TRAINING: For more information on Produce Safety Training, when the next class will be or to register for such a class visit the website below:

Produce Safety Alliance - Training & Resource

RECORDS: For additional information on what records are required under the rule as well as templates to satisfy the rule’s record requirement visit the following page: https://producesafetyalliance.cornell.edu/sites/producesafetyalliance.cornell.edu/files/shared/documents/Records-Required-by-the-FSMA-PSR.pdf?utm_source=PSA+May+2017+Newsletter&utm_campaign=PSA+May+2017+Newsletter&utm_medium=email

OUTREACH: As Vermont moves forward through the implementation of the Produce Safety Rule, the Agency will begin hosting outreach events, collaborating with associations and extension to host on-farm readiness reviews (voluntary on-farm assessments) and sending information in the mail to ensure growers affected by this rule are aware of these requirements. Check back soon!

ARE YOU COVERED? Click here to take our survey to help us determine whether your farm or business is covered and when your compliance date is.

Human Foods Preventive Control Rule

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

Human Food for Preventive Controls Rule New Requirements

The new requirements include maintaining and implementing 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.
  • ** Supplier Program (NEW): The plan must establish and implement a risk-based supplier program for raw materials and ingredients for which the receiving facility identifies a significant hazard and the hazard is controlled by the supplier.
  • Monitoring Procedures: The plan must document procedures to ascertain that preventive controls are consistently performed.
  • Corrective Actions: The plan must identify steps to take if preventive controls are not adequately implemented, to minimize the likelihood of problems reoccurring, to evaluate the food for safety, and to block problem food from entering commerce.
  • Verification: The plan must spell out verification activities and document that preventive controls are effective and consistently implemented.
  • ** Verification of Implementation and Effectiveness (NEW): Verification measures must include product testing and environmental monitoring, as appropriate to the facility, the food, and the nature of the preventive control.

A facility is required to maintain a written food safety plan and to keep records of each element of the plan. The rule adds a supplier approval and verification program, as well as environmental monitoring and product testing, to the requirements of the food safety plan.

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

Updated GMP Requirements

The Preventive Control Rule also updates Current Good Manufacturing Practice (cGMP) requirements. Updates include clarifications on protections against cross-contact of food by allergens, language changes, and deletion of certain provisions containing recommendations. Facilities that are exempt or subject to modified requirements in the new requirements for hazard analysis and preventive controls would generally be subject to cGMP requirements.

AT A GLANCE: For a quick overview of the Human Food Preventive Control Rule requirements click on the link below:

Human Food PC Rule ‘at a Glance’

TRAINING: For more information on Human Food Preventive Control Qualified Individual (PCQI) Training, when the next class will be or to register for such a class visit the website below:

Human Foods Preventive Controls Alliance - Training & Resource

RECORDS: For additional information on what records and/or how to write a food safety plan to satisfy the rule’s record requirement visit the following page:

Human Foods Food Safety Plan Template

Animal Foods Preventive Controls

Below are the key requirements for Animal Foods Preventive Controls rule.

  1. Current Good Manufacturing Practices (CGMPs)
    • The FDA has finalized baseline 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 they are 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 appropriately 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.
  2. 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, evaluate affected animal food for safety, and 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.
  3. Supply-chain program is more flexible
    • 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 who 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.
  4. 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 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.
  5. Feed Mills Associated with Farms (VERTICALLY INTEGRATED OPERATIONS) Are not covered
    • 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.

AT A GLANCE: For a quick overview of the Animal Food Preventive Control Rule requirements click on the link below:

Animal Food PC Rule ‘at a Glance’

TRAINING: For more information on Animal Food Preventive Control Training, when the next class will be or to register for such a class visit the website below:

Animal Foods Preventive Controls Alliance - Training & Resource

RECORDS: For additional information on how to meet the Animal Foods Preventive Controls requirements visit the following page:

Animal Foods Preventive Controls Compliance

FSMA Timeline Implementation

Check out where your company falls and timelines for implementation for rules that affect your business click here.

 

Contact

General Inquiries
Dominique Giroux
Produce Program Outreach & Education Coordinator
(802) 522-3132