The Food Safety Modernization Act (FSMA) amended the Food, Drug and Cosmetic Act (FDCA) of 1938, giving the Food and Drug Administration (FDA) the authority to mandate preventive-based controls across the food supply chain.
FSMA is the first major legislative reform of FDA's food safety authorities since 1938 and is shifting FDA’s focus from reacting to food contamination incidents to proactively preventing contamination.
Finalized in 2015, FSMA aims to strengthen the U.S. food safety system by stressing three fundamental strategies: prevention, increased surveillance, and better response and recovery in case of an outbreak of a foodborne illness The law covers U.S. food facilities and calls for greater oversight of the millions of food products entering the United States from other countries every year.
Foundational Rules
At every step of the food system supply chain, covered entities are required by law to comply with the standards created under FSMA. There are seven foundational rules that establish uniform minimum standards for food safety, starting with the growers and foreign suppliers, all the way to the packers, processors, transporters, and retailers of foods intended for human or animal consumption.
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Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: (referred to as the Produce Safety Rule (PSR)): establishes standards for the growing, harvesting, packing, and holding of produce for human consumption. This rule applies to most producers who grow fruits and vegetables and other raw agricultural commodities. Check out the PSR Overview page for more information.
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Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food: (referred to as the Preventative Controls Rule (PCR)): establishes current good manufacturing practices, hazard analysis, and risk-based preventive control for processed foods intended for human consumption.
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Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: (another PCR rule): establishes current good manufacturing practices, hazard analysis, and risk-based preventive control for processed foods intended for animal consumption.
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Foreign Supplier Verification Programs (FSVP): requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards.
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Mitigation Strategies to Protect Food Against Intentional Adulteration: aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply.
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Sanitary Transportation of Human and Animal Food: establishes requirements for shippers, loaders, carriers by motor or rail vehicle, and receivers involved in transporting human and animal food to use sanitary practices to ensure the safety of that food. The requirements do not apply to transportation by ship or air because of limitations in the law.
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Voluntary Qualified Importer Program (VQIP): voluntary fee-based program that provides expedited review and import entry of human and animal foods into the United States for participating importers.
A list of finalized rules and guidance documents can be found on FDA’s webpage.
Maryland producers must also be aware of local regulations they must comply with, including the rules for acidified foods.
Produce Safety Rule (PSR)
If you grow, pack, process, or sell fresh produce, this regulation may apply to you. The Produce Safety Rule, outlined in Section 105 of FSMA, establishes science-based minimum standards for safe production and harvesting of fresh fruits and vegetables. These standards are based on a foundation of Good Agricultural Practices (GAPs).
What does the Produce Safety Rule cover?
Figuring out what produce is covered by Produce Safety Rule is more easily done by first understanding what is not covered. The rules do not apply to:
- Produce that is used for personal or on-farm consumption,
- Produce that is not a raw agricultural commodity (RAC) (A raw agricultural commodity is any food in its raw or natural state).
- Produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance (e.g. via a “kill step”) as long as certain disclosures are made and written assurances are received, with appropriate documentation.
- Produce that is rarely consumed raw. The “rarely consumed raw” list at 21 CFR 112.2(a)(1) is exhaustive.
Any fruits and vegetables - including mushrooms, sprouts (irrespective of seed source), peanuts, tree nuts, and herbs - that are not explicitly excluded are thereby covered by FSMA. Keep in mind that a crop is still subject to all applicable requirements of the FDCA even if it is exempt from the Produce Safety Rule.
The rule is divided into several parts, including standards for:
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Agricultural water, for production and post-harvest uses: Agricultural water, as defined in the Produce Safety Rule, is water used in covered activities on covered produce where water is intended to, or is likely to, contact covered produce or food contact surfaces. The general requirement is that all agricultural water must be safe and of adequate sanitary quality for its intended use. There are separate standards for production water (water used during growing activities for covered produce, other than sprouts) and postharvest water ( water used during and after harvest, including during packing or holding activities) to manage the risks of microbial contamination in each stage. Check out the Agricultural Water page for more information on standards and how PSR and GAP standards differ.
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Biological soil amendments of animal origin (BSAAO): The definition of BSAAO, in 21 CFR 112.3, means any soil amendment which consists, in whole or in part, of materials of animal origin, such as manure or non-fecal animal byproducts. The PSR contains requirements related to the safe use of biological soil amendments of animal origin, including raw manure. The Produce Safety Alliance has a fact sheet on what producers who buy compost or soil amendments from third-party suppliers along with a model Certification of Conformance Form. The Maryland Department of the Environment maintains a list of commercial composters that are inspected and permitted by MDE and which the Department of Agriculture will accept as a verified supplier.
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Domesticated and wild animals: Farmers must take reasonable precautions to prevent contamination of covered produce, food contact surfaces, and food-packing materials and assess fields used to grow covered produce for evidence of contamination by grazing, domestic, or wild animals.
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Equipment, tools, buildings, and sanitation: Subpart L of Part 112 contains requirements for covered farms regarding adequacy of equipment, cleaning and sanitizing of equipment, and storage and maintenance of equipment (see especially 21 CFR 112.123).
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Production of sprouts: Because sprouts have frequently been associated with outbreaks of foodborne illness, the PSR includes specific requirements in Subpart M for most sprouts, which are in addition to the other applicable provisions of the PSR. For specific rules and standards, visit the Sprouts Safety Alliance website.
Recordkeeping
Recordkeeping is a large part of complying with the PSR. Records facilitate verification that growers are complying with standards. They also help identify patterns or problems, which are important for growers to recognize and then take steps to minimize the likelihood of food contamination.
The general recordkeeping standards require records to include:
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Name and location of the farm;
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Actual values and observations collected during monitoring activities;
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An adequate description of the produce applicable to the record (e.g., commodity name, specific variety, or other identifier, such as a lot number);
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Location of the growing area or other area applicable to the record; and
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Date and time that an activity was performed or observed.
The records must be taken at the time an activity is performed or observed, must be accurate and legible, and must be dated and signed by the person doing the activity. To ease recordkeeping, check out these Produce Safety Alliance record keeping templates.
The Agriculture Law Education Initiative has a video detailing how to keep FSMA compliant records: Produce Safety Rule, FSMA, and Recordkeeping (37:53) by Sarah Everhart. January 2018.
On-Farm Readiness Reviews
The Maryland Department of Agriculture offers free On-Farm Readiness Reviews (OFRR) to help farmers better understand and meet the requirements of the federal Food Safety Modernization Act Produce Safety Rule. To request a free OFRR, fill out MDA’s request form online.
Useful Resources
Compliance Dates & Exemptions (PSR)
Farms that do grow crops covered by the PSR are required to comply with the FSMA Produce Safety Rule. The law determines exemptions based on the average annual income of the farm over the previous three year period.
Very small businesses with $25,000 to $250,000 in average annual produce sales during the previous three year period: January 27, 2020
Small businesses with more than $250,000 and up to $500,000 in average annual produce sales during the previous three year period: January 28, 2019
Businesses with more than $500,000 in produce sales: January 26, 2018
Compliance dates for certain aspects of the water quality standards and related testing and recordkeeping provisions are four years beyond the compliance dates for the rest of the final rule
For a comprehensive list of compliance dates for all rules, click here.
Qualified Exemption
A farm growing covered produce may be eligible for a qualified exemption and modified requirements if it meets two requirements:
(1) The farm must have food sales averaging less than $500,000 per year (adjusted for inflation) during the previous 3 years
(2) The farm's sales to qualified end-users is 50.1% or more of total sales.
NOTE: The $500,000 threshold applies to the value of ALL food sales, not just sales of covered produce. Food is defined in Section 201(f) of the Federal Food, Drug, and Cosmetic Act, including but not limited to, processed food, hay, commodities like corn and soybeans, dairy, livestock, and produce.
What is a Qualified End-User?
A qualified end-user is defined in the FSMA PSR as either:
(1) the consumer of the food, or
(2) a restaurant (including places like food stands, hospital cafeterias, catering) or retail food establishment (e.g. grocery and convenience stores) that is located in the same State or the same Indian reservation as the farm or not more than 275 miles away.
Farmers who engage in any direct marketing should carefully track what percentage of their sales each year are made to qualified end-users. To ease recordkeeping, check out these Produce Safety Alliance record keeping templates
For more details on some of the trickier end-user questions, see the FDA Compliance Guidance for the Produce Safety Rule.
The National Sustainable Agriculture Coalition has a useful flowchart to help producers understand how the Produce Safety Rule applies to an operation.
Exempt Businesses
The Produce Safety Rule does not cover farms that have an average annual value of produce sold during the previous 3-year period of $25,000 or less (adjusted for inflation). To determine whether a farm is potentially a covered farm with respect to the threshold in 21 CFR 112.4(a), the farm would need to calculate the average annual monetary value of their produce sales during the previous three years.
What to Do If You're PSR Qualified Exempt?
Qualified exempt farms are still subject to three parts of the FSMA regulations:
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General provisions:
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The farm name and complete business address of the farm must be disclosed “prominently” in the produce package label or at the point of purchase through a poster, sign, placard or document. In the case of internet sales, use an electronic notice.
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Compliance and enforcement:
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Qualified exempt farms must comply with labeling requirements and retain documents to support eligibility.
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Deadline for labeling requirements: January 1, 2020
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Retention of records supporting eligibility:
- Over $250,000 in food sales – January 26, 2016
- $25,000 to $250,000 in food sales – January 26, 2017
3. Withdrawal of a qualified exemption:
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FDA reserves the ability to revoke your “qualified exempt” status in certain circumstances.
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The qualified exemption may be withdrawn in the event of an active investigation of an outbreak that is directly linked to the farm, or if it is necessary to protect the public health and prevent or mitigate an outbreak based on conduct or conditions on the farm that are material to the safety of the produce.
The Agriculture Law Education Initiative's webinar - So You’re Qualified Exempt - Now What? - provides information what producers need to know about complying with Qualified Exempt modified requirements.
Comparison of GAP and PSR Certification Requirements
Maryland growers who already voluntarily comply with the requirements of a Good Agricultural Practices (GAP) program often ask what more they will have to do under the Food Safety Modernization Act’s Produce Safety Rule (PSR). They might wonder if they are already satisfying the legal obligations and want to know how to prove compliance to inspectors.
The comparison table below is meant to provide an overview and help producers understand the general similarities and differences between GAP and PSR requirements so they can assess what steps they might need to take to bring their operation into compliance with Federal and State laws.
The main recommendations to help with FSMA PSR compliance for producers already GAP certified are:
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Have the food safety officer/manager or other employee attend a grower training course (events link);
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Develop a food safety training program for farm employees;
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Inspect your water distribution system and learn more about your water quality through periodic testing;
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Evaluate compost/soil amendment techniques and use to satisfy FDA microbial standards;
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Identify tools and equipment in your harvesting and packing which are food contact surfaces and develop a cleaning and sanitizing regime for those objects/surfaces.
Most GAP programs currently include some requirements that are not required under FSMA, including:
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Documented Farm Food Safety Plan;
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Designated food safety officer/manager— this person would ideally be the one attending the FDA-approved course;
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Traceability records (except on-farm food processing activities that require traceability under the Preventive Controls Rules);
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Pesticide residues testing (GlobalGap and GroupGAP);
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Mock recall plan; and
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Farm sewage treatment records.
Agricultural Water
Agricultural water is defined in the Produce Safety Rule as water used in covered activities on covered produce where water is intended to, or is likely to, contact covered produce or food contact surfaces.
The general requirement in the PSR is that all agricultural water must be safe and of adequate sanitary quality for its intended use (Section 112.41). There are separate standards for production water and postharvest water to manage the risks of microbial contamination in each stage.
In addition to monitoring water quality, you must also inspect your agricultural water systems annually to identify conditions that are reasonably likely to introduce a hazard into or onto covered produce or food contact surfaces (Section 112.42).
The main differences to keep in mind are that PSR requires:
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Specific testing methods to be used when testing your water;
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Test results with numeric results for production water;
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Farmers to establish a baseline water quality for each source of water used on covered crops;
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Water distribution system should be inspected and secured
Useful Resources:
Preventive Controls Rules (PCR) Overview
The Preventive Control Rules for Human Food and the Preventive Controls Rule for Human Food of FSMA create new requirements and update existing standards for facilities that manufacture, process, pack, or hold food for humans & animal consumption. The PCRs operate to ensure all food facilities produce safe foods and that the FDA can quickly determine the location and source of potential food-borne illness outbreaks and notify affected facilities.
The key provisions of both of the Preventive Controls Rules include:
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Hazard Analysis: Facilities must have a food safety plan that addresses multiple aspects.
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A Hazard Analysis and Critical Control Point (HACCP) Plan is required and must identify and evaluate hazards for each type of food manufactured, processed, packed, or held at the facility, including the potential biological, chemical, and physical hazards.
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A critical control point (CCP) is a point, step, or procedure in a food process where control is essential to prevent, reduce, or eliminate food safety hazards. The types of preventive controls you use will depend on the facility and the food.
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Preventive and monitoring controls: The written food safety plan must also identify preventive and monitoring controls that will significantly minimize or prevent hazards. Preventive controls include process controls, food allergen controls, sanitation controls, supply-chain controls, a recall plan, and may also include worker training on the principles of food hygiene and food safety, and other current good manufacturing practices.
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Corrective actions & Corrections: Also in the food safety plan must be considerations for the oversight and management of the preventive controls, including corrective actions and corrections that can be timely taken to identify and correct minor, isolate problems that occur during food production to reduce the likelihood that a problem will recur. Steps must also be outlined to evaluate affected food for safety and to prevent it from entering commerce. Corrective actions must be documented with records.
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Verification of implementation and effectiveness: The food safety plan must also provide for activities that verify that the preventive controls are consistently implemented and effective. Verification measures include scientific evidence that a control is capable of effectively controlling an identified hazard, calibration and accuracy checks of process monitoring instruments (e.g. thermometers) and reviewing the records to ensure employees are monitoring and taking corrective actions when necessary.
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Current “Good Manufacturing Practices” (CGMPs): The rule makes some CGMPs for education and training binding to ensure employees are qualified to perform their duties. The rule also explicitly provides that allergen cross-contact is addressed by the CGMPs.
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Supplier programs: The rule mandates that a manufacturing/processing facility have a risk-based supply chain program for those raw material and other ingredients for which it has identified a hazard requiring a supply-chain applied control. Manufacturing/processing facilities that control a hazard using preventive controls, or who follow requirements applicable when relying on a customer to control hazards, do not need to have a supply-chain program for that hazard. For Supply-Chain Program compliance dates, go to: https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-compliance-dates#HumanFood
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Preventive Controls Qualified Individual (PCQI): The PCR also requires that the food safety plan be developed and applied by a Preventive Controls Qualified Individual (PCQI) who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to develop and apply a food safety system. Job experience may qualify an individual to perform these functions if such experience has provided an individual with knowledge at least equivalent to that provided through the standardized curriculum. In general, FDA will assess the adequacy of a facility’s food safety plan rather than an individual’s documented qualifications. Deficiencies in the food safety plan indicate that a PCQI may need additional training specific to the rule, irrespective of documented training and experience.
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Farms that pack and hold for other farms: The rule categorizes on-farm activities as either primary or secondary.
Useful Resources:
Food Safety Preventive Controls Alliance (FSPCA) is the organization entrusted with overseeing PCR trainings and providing educational materials to producers.
Out-of-State PCR trainings list: https://fspca.force.com/FSPCA/s/courselist?language=en_US
Key Facts about Preventive Controls for Human Food (FDA)
Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (FDA)
Guidance for Industry: Determination of Status as a Qualified Facility (FDA)
PCR Applicability & Exemptions
Just like with the Produce Safety Rule, the PCRs also exempt some facilities and allow certain facilities to qualify for modified (reduced) obligations, depending upon the volume of annual sales and destination of products. The National Sustainable Agriculture Coalition has a useful flowchart to help producers understand if and how the PCR applies to their operation, along with detailed information on what is considered a facility.
Who is Exempt from PCR?
Farms in general are not considered facilities that must register under the FD&C Act. The law defines farms in two ways - as either a primary production farm or a secondary activities farm.
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Primary production farm: Farms that pack, hold, or minimally processes (e.g. dehydrating, ripening, or packing and labeling raw agricultural commodities) the crops grown/raised and harvested on-site as part of their primary farming operations are exempt and do not need to register as a facility with the FDA. Basically, any facility that is already subject to the Produce Safety Rule standards.
For example, a farmer that grows tomatoes and sells them at a roadside stand located on the farm is exempt from registration. The rule also exempts certain on-farm low-risk manufacturing/processing activity/food combinations performed by small and very-small businesses. The full list of exempt on-farm primary activities is provided in 21 CFR §1.227.
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Secondary activities farm. A secondary activities farm is an operation, not located on a primary production farm, devoted to harvesting (such as hulling or shelling), packing, and/or holding of raw agricultural commodities, provided by a primary production farm(s) that grows, harvests, and/or raises the majority of the raw agricultural commodities sent to it is owned or jointly owned a majority interest in the secondary activities farm.
A secondary activities farm may also conduct those additional activities allowed on a primary production farm.
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Cottage food retailers, like someone who makes jams and jellies to sell at farmers’ markets, who operate out of their private residence are not considered facilities and therefore not subject to PCR requirements. Additionally, retailers who are subject to the “low-acid canned food” requirements of 21 CFR part 113 are exempt to the extent that the microbiological hazards are already regulated under part 113 and any facility (not a private residence) is in compliance with part 113.
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Retail food establishments generally are not subject to the Preventive Controls Rules. For example, farmers’ markets, community supported agriculture programs (CSA), and other direct-to-consumer sale structures come under the definition of retail food establishment and are not subject to the Preventive Controls Rule.
Who does PCR apply to?
The PCR applies to facilities and farm-mixed type facilities that manufacture, process, pack, or hold food for human consumption. The key terms to understand in order to determine whether PCR applies to an operation are “facility”, “mixed-type facility”, “manufacturing/processing”, “packing” and “holding”.
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A “facility” is defined as “any establishment, structure, 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 consumption in the United States.”(21 CFR 1 § 227(b)(2)).
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The term “mixed-type facility” means an establishment that engages in both activities that are exempt from registration and activities that require the establishment to be registered. For example, a farm that grows apples and processes them into apple cider or juice for sale to a distributor is mixed-type facility that is required to register under the PCR.
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Manufacturing/processing is broadly defined in the rule as making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food, including food crops or ingredients. For a complete list of included activities, visit FDA’s, Questions and Answers Regarding Food Facility Registration (7th Edition), https://www.fda.gov/media/85043/download
Some examples of manufacturing/processing activities include:
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Baking,
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canning,
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distilling,
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drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins),
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extracting juice,
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freezing,
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grinding,
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labeling,
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packaging (including modified atmosphere packaging),
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pasteurizing,
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treating to manipulate ripening,
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trimming,
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washing, or waxing.
If an activity is part of harvesting, packing, or holding, then it is not considered manufacturing or processing. However, some activities can fall within several categories.
Who is Subject to PCR Modified Requirements?
Certain businesses are exempt from the Hazard Analysis and Risk-based Preventive Controls (HARPC) and the Supply Chain Program requirements. These exemptions from certain requirements are available to “Qualified Facilities”.
A “qualified facility” is either:
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A “very small business” is a business, including any subsidiaries and affiliates, averaging less than $1,000,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (e.g., held for a fee); OR
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A facility (when including the sales by any subsidiary; affiliate; or subsidiaries or affiliates, collectively, of any entity of which the facility is a subsidiary or affiliate) to which both of the following apply:
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During the 3-period preceding the applicable calendar year, the average annual monetary value of the food manufactured, processed, packed or held at such facility that is sold directly to qualified end-users (consumers, or local restaurants and retail food establishments not more than 275 miles from the facility) during such period was over 50% of total average annual food sales; and
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The average annual monetary value of ALL food sold during the 3-year period preceding the applicable calendar year was less than $500,000, adjusted for inflation.
To be eligible for modified requirements, a qualified facility is required to notify FDA about its status and attest that it is either:
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Addressing identified hazards through preventive controls and monitoring the preventive controls; or
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Complying with applicable non-Federal food safety regulations, and notifying consumers of the name and complete business address of the facility where the food was manufactured or processed.
A qualified facility must submit these notifications to FDA during the same two year timeframe that the facility is required to update its facility registration. An otherwise Qualified Facility that does NOT notify FDA is subject to the requirements for Hazard Analysis and Preventive Controls.
“Farm mixed-type facilities” under certain circumstances:
Certain manufacturing, processing, packing and holding activities conducted on-farm by small or very small businesses are not subject to the requirements for hazard analysis and risk-based preventive controls if these are the only activities that would be subject to the requirements for hazard analysis and risk-based preventive controls. The exemption only applies to the low-risk activity/food combinations listed in the regulation.
PCR Facility Registration & Compliance Dates
The owner, operator, or agent in charge of any domestic or foreign facility that manufactures/processes, packs, or holds food for human or animal consumption in the U.S. must register with the FDA, unless an exemption applies.
Decision Tree: Food Facility Registration: Who, How, and When?
Food Processing Facility Registration
Beginning January 4, 2020, registrants must submit their registration or registration renewal to FDA electronically, unless FDA has granted a waiver.
The Owner, Operator, or Agent in Charge of the Facility can submit a facility’s registration or registration renewal electronically via FURLS Food Facility Registration Module (FFRM) at https://www.access.fda.gov. You will need an FDA Industry Systems (FIS) account ID and password in order to access the electronic system. More information is available about the FIS at https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration.
Registration for Acidified and Low-Acid Foods
If you are producing an acidified or low acid canned food, you must register your facility and your scheduled process with the FDA as well. This is in addition to registering your facility as part of the Bioterrorism Act.
Your facility must be registered using FDA form 2541. Instructions for filling out form 2541 are listed on the FDA website.
A PDF of form 2541 can be found here:
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM076778.pdf.
In addition to registration of your facility, you must also fill out a scheduled process and submit your information to the FDA using form 2541A. This form can be found here: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM07678...
Approving Authorities: https://smadc.com/farmer-resources/tutorials/acidified-foods/
PCR Compliance Dates
Covered facilities that manufacture, process, pack, or hold food will fall into one of three categories to determine compliance dates under the Preventive Controls Rule:
Generally, very small and small businesses had a longer period to bring themselves into compliance.
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A very small business is a business (including any subsidiaries and affiliates) averaging less than $1 million per year (adjusted for inflation), during the 3-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed or held without sale (e.g., held for a fee).
For the most current compliance date information, visit the FDA webpages:
