1. I’ve heard that FSMA includes food safety requirements for food transportation. Do these requirements apply to my food business?
FSMA’s rule on Sanitary Transportation of Human and Animal Food sets food safety standards for vehicles and equipment used to transport food. The rule covers any business that is a shipper, loader, motor or rail carrier, or receiver of human and animal foods, unless that business meets one of the exemptions in the rule.
According to the Sanitary Transportation Rule:
- A shipper is an operation that arranges for the transportation of food in the United States by a carrier or multiple carriers, including the manufacturer of the food or a broker that distributes it;
- A loader is an operation or person that physically loads food onto a motor or rail vehicle;
- A carrier is an operation or person that physically moves food by rail or motor vehicle in commerce within the United States;
NOTE: ‘Carrier’ does not include parcel delivery services that transport food (such as UPS or FedEx). - A receiver is an operation or person in a food supply chain that receives food transported in the United States.
2. Those categories are very broad. What are the exemptions from the rule?
Several classes of operations are exempt from compliance with the Sanitary Transportation Rule even if they fall within those definitions of shipper, loader, carrier, and receiver:
- A business that meets FSMA’s definition of a farm. For information on the FSMA Farm Definition, see the FSMA FAQ ‘Is My Food Business a Farm?’
- An establishment engaged in food transportation that has less than $500,000 in average annual revenues over the previous three years, as adjusted for inflation. For 2019, this means the operation had 2016-18 average annual revenues less than $550,5511. This threshold amount is good for 2019. The dollar threshold for this exemption are to be adjusted annually for inflation, and FDA publishes the adjusted numbers every April.
- An operation that only transports live food animals that are not molluscan shellfish.
- An operation that only transports Grade “A” milk and milk products that is permitted and inspected under the National Conference on Interstate Milk Shipments (NCIMS).
- An establishment that ships, carries, or receives food and has a permit from a local, state, or tribal agency to distribute food directly to retail customers, including restaurants, supermarkets, and home grocery delivery operations.
- An operation that only transports human food byproducts to be used as animal food without further processing, such as byproducts sold directly to farmers to be fed to livestock.
- An operation that only transports food that is completely enclosed by a container and that does not require refrigeration or any other form of temperature control for safety.
- An establishment that only transports food that is transshipped through the United States to another country, or that is imported for future export and neither consumed nor distributed in the United States.
- An operation that only transports compressed food gases (for example, carbon dioxide, nitrogen or oxygen authorized for use in food and beverage products), or food contact substances.
3. What if my business ships, loads, carries, or receives food and doesn’t meet any of these exemptions?
You are covered by the STR. Under the rule:
- Vehicles and transportation equipment you use must be designed and maintained to ensure that they do not cause the food that they transport to become unsafe. They must be adequately cleaned prior to loading, and must be able to maintain the proper temperature if temperature control is necessary for the safe transportation of the food.
- You must ensure that food that requires temperature control for safety is transported at the proper temperature.
- You must prevent ready-to-eat food from touching raw food.
- You must protect food from contamination by non-food items in the same load or a previous load.
- You must protect food from unintentional contact with food allergens.
- You must ensure that the personnel involved in physically moving foods are trained in sanitary transportation practices.
- You must maintain records of written transportation procedures, transportation agreements, and carrier personnel training, and keep those records for as long as 12 months, depending on the type of record and when the transportation activity occurs.
The rule gives shippers the primary responsibility for determining the transportation operations necessary to meet these requirements. Shippers must develop and implement written procedures to ensure that:
- equipment and vehicles are in appropriate sanitary condition;
- food transported in bulk is not contaminated by cargo previously carried in a bulk container; and
- food that requires temperature control for safety is transported under adequate temperature control.
NOTE: Shippers may use contracts to assign some of their responsibilities to other entities in the supply chain.
The FDA has developed resources to assist entities covered by the STR to comply with the rule, including a compliance guide for small businesses and a training module. For more information, see the FDA’s website on the STR.
1. Is my food or animal feed business required to register with the FDA?
Understanding if your business is required to register with the FDA is essential to determining whether
FSMA’s Preventive Controls Rules for processing, packing, or holding human food or animal feed govern your
operation. Under the Bioterrorism Act of 2002, all domestic and foreign food and feed ‘facilities’ are required
to register with FDA. The agency defines ‘facility’ as an:
- establishment; structure; or group of structures under one ownership at one general physical
location; or mobile food business, that - manufactures/processes, packs, or holds food for consumption in the United States.
FDA further defines manufacturing/processing, packing, and holding.
- Manufacturing/processing means: “making food from one or more ingredients, or synthesizing,
preparing, treating, modifying or manipulating food, including food crops or ingredients.” - Holding means: “storage of food and also includes activities performed incidental to storage of a
food (e.g., activities performed for the safe or effective storage of that food, such as fumigating food
during storage, and drying/dehydrating raw agricultural commodities when the drying/dehydrating
does not create a distinct commodity (such as drying/dehydrating hay or alfalfa)). Holding also
includes activities performed as a practical necessity for the distribution of that food (such as
blending of the same raw agricultural commodity and breaking down pallets).” - Packing means: “placing food into a container other than packaging the food and also includes repacking and activities performed incidental to packing or re-packing a food (e.g., activities performed
for the safe or effective packing or re-packing of that food (such as sorting, culling, grading, and
weighing or conveying incidental to packing or re-packing).”
As a general rule, all businesses that manufacture, hold, or pack food are required to register as food facilities
with the FDA, based on the Bioterrorism Act of 2002. However, the Bioterrorism Act provides several
exceptions to the facility registration requirement. The following are domestic establishments that do not
have to register with FDA:
a. A private residence of an individual(s).
b. A farm. FSMA regulations provide a complex definition of what counts as a ‘farm’, as FDA considers
many of the activities that are normal parts of farming to be processing, packing, or holding if they
take place somewhere other than a farm; to learn the details of the ‘farm’ definition, see the FSMA
FAQ ‘Is My Food Business a Farm?’
c. A retail food establishment. FDA defines ‘retail food establishment’ as a business that manufactures packs, or holds food and sells more than half those products directly to consumers, including through on-premises sales, farmers markets, community-supported agriculture, roadside stands, online, mail order and other direct marketing platforms.
d. A restaurant.
e. A nonprofit food establishments in which food is prepared for, or served directly to, the consumer.
f. A fishing vessel—including vessels where harvested fish are headed, eviscerated, or frozen to
prepare them for holding on board the harvest vessel. Fishing vessels that do any further processing
to prepare fish or shellfish for market, however, must register.
g. A transportation vehicle if it only holds food only in the usual course of business as a carrier.
h. A facilities regulated exclusively, throughout the entire facility, by the U.S. Department of
Agriculture under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg
Products Inspection Act.
NOTE: If you operate a farm and also do food processing, packing, or holding that is not included within the
definition of ‘farm’, your business may be a ‘farm mixed-type facility’, and you may have to register with FDA
for those non-farming activities. To learn more, see the FSMA FAQ ‘Is My Business a Farm Mixed-Type
Facility?’
NOTE: Depending on the kinds of foods and activities, a retail food establishment may be regulated by the
state or local health department, or may be subject to ‘cottage food’ regulations if your state has them.
2. My business doesn’t fall into any of these exceptions, or is a farm mixed-type facility. How do I register?
If you are operating a facility that is required to register with FDA, you are technically supposed to register
before commencing any food or feed processing, packing, or holding activities. If you have already started
those activities, you should register right away. FDA offers a step-by-step guide to registering your facility.
Beginning in January, 2020, registration must be submitted electronically.
You must provide the following information as part of the registration process:
- The name, address, and phone number of your business, and of the parent company of your
business if it is a subsidiary of another entity; - The names, addresses, and phone numbers of the people who own and operate your facility;
- An emergency contact phone number;
- Any additional trade names that your business uses;
- All the categories of food products your business makes, packs, or holds. You will select from a list of
food categories provided by FDA.
REGISTRATION RENEWAL: After your initial registration, you must renew your registration and update any changed information between October 1 and December 31 of every even-numbered year.
3. I have previously registered my business, but my business actually meets one of the exclusions. Can I cancel my registration?
If your business meets any of the exceptions or exemptions, then you do not have to comply with FSMA’s
Preventive Controls Rules (PC Rules). If you have registered when you’re not required to do so, you should
cancel that registration to avoid the risk of an FDA-authorized agent arriving at your business to conduct a PC
Rule inspection. FDA provides a tutorial for how to cancel your registration online. You may also cancel your
registration by filling out FDA’s form 3537a and faxing the completed form to (301) 436-2804, or by mailing it
to:
U.S. Food and Drug Administration/Food Facility Registration
5001 Campus Drive
HFS-681
College Park, MD 20993
4. My business is a facility that must register with FDA. How do I know if I’m covered by the PC Rules?
If your business is a farm mixed-type facility, see the FSMA FAQ ‘Is My Business a Farm Mixed-Type Facility?’
to learn more about what portions of the PC Rules might apply to your operation.
If your business is any other type of registered facility, see the FSMA FAQ ‘What are the Basic Requirements
of FSMA’s Preventive Controls Rules for Human Food?’ to learn more about which parts of the PC Rules
might apply to your operation.
My food business has to register as a food facility with FDA, and is required to follow Good Manufacturing Practices (GMPs). What are FSMA’s GMP requirements?
FSMA applies the federal GMP regulations to almost (Off-farm facilities that only package, pack, and hold produce; and farm mixed-type facilities that are drying/dehydrating raw agricultural commodities to produce a distinct product (with no other processing such as pitting, slicing, freezing, etc.) may choose to follow relevant portions of the FSMA Produce Rule in carrying out those activities, instead of applying GMPs. For more information, see the FSMA FAQs ‘Is My Produce Packing Operation Covered by the PC Rules?’ and ‘Is My Business a Farm Mixed-Type Facility?’) all food products regulated by the FDA.
GMPs are intended to ensure that ingredients, finished products, and packaging materials are handled safely, and that food products are processed in a suitable environment. GMPs are the basis of a food safety program for your facility, and address the microbial, chemical, and physical hazards relevant to the products that you manufacture, pack, or hold that could cause illness or injury to consumers of those products. The GMP regulations are general in nature, and are intended to allow your business the flexibility to develop and implement practices appropriate to your food products.
NOTE: FDA’s GMP rules do not apply to facilities that are regulated exclusively, throughout the entire facility, by the U.S. Department of Agriculture under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act.
The GMP rules address nine aspects of making and handling food:
- Personnel: Covers food safety and hygiene training for employees, food worker hygiene practices, and preventing ill or infected employees from contaminating food.
- Plant and Grounds: Addresses food facility design, construction, and maintenance elements necessary to avoid contamination, such as: preventing pests from entering the facility; ensuring walls, floors, ceilings are cleanable; separating activities that could cause cross-contamination; providing adequate space for sanitary arrangement of equipment and storage of materials; and controlling areas around the facility that could harbor pests or pathogens.
- Sanitary Operations: Covers general cleaning, sanitizing, and maintenance actions necessary to ensure the plant and all fixtures within it are kept in good repair and maintained in a sanitary condition. Cleaning must be conducted in a manner that minimizes the possibility that foods, or equipment surfaces that contact food, will be contaminated by microbial or chemical hazards, including the eight major food allergens: milk, fish, crustacean shellfish, peanuts, tree nuts, wheat, soybeans, and eggs.
NOTE: Your allergen control program must also ensure any of your products that intentionally contain any of the eight major food allergens are accurately labeled, including monitoring to verify that any labels used on finished products are correct and properly affixed to the product or package. For more information, see the FSMA FAQ ‘What Are FSMA’s Allergen Labeling Requirements?’ - Sanitary Facilities and Controls: Covers water supply, plumbing, waste water disposal, and toilet and handwashing facilities. In general, any water that comes into contact with food, food contact surfaces, or processing equipment must be safe and of adequate sanitary quality.
- Equipment and Utensils: Requires that equipment and utensils be designed, constructed, and installed so that they are adequately cleanable, minimize potential pathogen contamination, and do not adulterate food with lubricants, fuel, metal fragments, contaminated water, other debris, allergen cross-contamination, as well as. Also requires that food contact surfaces are made from nontoxic materials, and that instruments used to measure critical aspects of food safety (such as pH, water activity, temperature) are calibrated to ensure accuracy.
- Processes and Controls: Addresses standard operating procedures in your facility to:
- ensure raw materials are free of contamination, and are stored and conveyed so as to prevent contamination of your food products from microbial, physical or chemical hazards (including allergens);
- monitor for factors that could prevent or cause contamination, such as time, temperature, humidity, and water activity
- minimize the potential that your production processes introduce hazards, such as by improper cooking or contact of food with uncontrolled sources of contamination; and
- provide for traceability through recordkeeping.
- Warehousing and Distribution: Requires that food be stored and transported under conditions that will protect against allergen cross-contact; prevent deterioration of the food and the container; and protect against microbial, chemical, or physical contamination.
- Holding and Distribution of Human Food By-products for Use as Animal Food: Covers procedures to avoid contamination of human food by-products that will be used as animal food without additional manufacturing or processing.
- Defect Action Levels: Addresses steps to prevent foods that don’t meet your quality assurance standards from becoming a source of contamination for other foods in your facility.
It is your responsibility to take all reasonable measures and precautions to maintain the basic operational and environmental conditions required to produce safe foods. Communicating the GMP rules with employees through training can minimize food safety risks significantly.
There are many resources and educational programs to help food businesses understand the details of GMPs and apply those practices in producing and handling foods. Options for getting started include:
- Cornell University’s online GMP course
- North Carolina State University’s course
- Carolina Farm Stewardship Association’s GMP manual
1. My human food business doesn’t fit any HARPC exception. What are the requirements?
Hazard Analysis and Risk-based Preventive Controls (HARPC) in general are your business’ plan and efforts to identify and address food safety risks—including pathogens, chemicals, toxins, unapproved additives, allergens or physical hazards such as glass or metal fragments—that might reasonably affect the foods you make or handle. HARPC under the PC Rule requires you to have a food safety plan that includes seven specific elements for every single food you produce.
- Identification of food safety hazards: For every food, understand and document the relevant contamination risks, and the best steps to prevent those hazards.
- Preventive controls: For every food, implement practices that best prevent and minimize the identified hazards.
- Monitoring: Run checks to make sure that your preventive controls and food safety plan are actually being applied, and do so often enough to catch problems.
- Corrective actions: You must have a written plan that you follow when you do find evidence of a food safety problem that includes finding the cause and fixing it.
- Recall program: You must have a recall plan and be ready to implement it should you put potentially products into the supply chain that are contaminated, mislabeled, or otherwise in violation of food safety rules.
- Verification: Your plan must include actions to assess that preventive controls and corrective actions are actually working to prevent contamination.
- Reanalysis: You must repeat the analysis of your hazards and preventive controls at least every three years, or more often if you make changes in your food processing or handling program or learn of a new threat.
Each of these elements of your HARPC program must be documented extensively, including the food safety plan itself, the procedures for carrying out the various steps of the plan, and that the procedures are being executed. All of these documents are subject to review in a facility inspection under FSMA.
NOTE: Facilities that are covered by existing FDA rules for thermally processed low-acid canned foods are exempt from HARPC and SCP with respect to microbial hazards. These facilities still must have HARPC programs to address chemicals, toxins, unapproved additives, allergens or physical hazards.
2. What are the SCP requirements?
You must establish a Supply Chain Program (SCP) if your hazard analysis identifies a safety risk in any food product or ingredient coming into your facility that your suppliers need to address before you receive that food. So the SCP requirement would not apply if your facility applies a kill step to the foods you receive or the products that you make using them. However, if you are making ready-to-eat foods using raw produce, such as fresh cut fruit or coleslaw, your SCP must include verification that the farms that grew the raw produce and any distributors in between followed food safety practices to minimize contamination risk.
If you are required to have an SCP for a food or foods you make or handle, you can only use raw materials or ingredients obtained from ‘approved suppliers’ that you have verified are applying appropriate hazard controls. It is your responsibility to verify those suppliers through onsite audits, including third-party audits; sampling and testing of the raw material or ingredients; reviewing the supplier’s food safety records; or by other activities, depending on the risk associated with the food. If the food coming into your facility poses a significant risk of causing serious illness, you can only receive the food if the supplier has had an audit, and in some cases it must be at least an annual audit.
NOTE: You are allowed to receive products from ‘qualified exempt’1 farms or other facilities even if they do not have an audit, but those establishments must provide you written assurance:
- once per year that they are in fact qualified exempt; and
- every two years that they know they are subject to the Food, Drug and Cosmetic Act’s prohibition on introducing adulterated food into commerce.
1. My food facility meets the criteria for a Qualified Exempt Facility. Does FSMA still apply to me?
Qualified Exempt Facilities (QEFs) do not have to comply with the FSMA PC Rules’ Hazard Analysis and Risk-Based Preventive Controls (HARPC) or Supply Chain Program (SCP) requirements. However, there are special requirements for QEFs related to attestation, notice to consumers, and losing QEF status.
And while your QEF is not required to comply with the full HARPC provisions, you are subject to FSMA’s Good Manufacturing Practices rules (GMPs). To learn more about the GMP requirements, see the FSMA FAQ ‘What Are FSMA’s GMP Rules?’
2. What are the attestation requirements?
You must submit two written declarations (‘attestations’) to FDA to establish your QEF status.
- An attestation that your average annual food sales for 2016-18 were less than $1,101,1031 (This threshold amount is good for 2019. The dollar thresholds for the qualified exemptions are to be adjusted annually for inflation, and FDA publishes the adjusted numbers every April.). You do not have to submit the sales records to support the attestation, but you must retain sufficient financial records to prove your claim if requested.
- An attestation that you have either:
- identified potential hazards associated with the food being produced, implemented preventive controls to address the hazards, and are monitoring the performance of the preventive controls to ensure that they are effective; OR
- are in compliance with State, local, county, tribal, or other applicable non-Federal food safety law, including relevant laws and regulations of foreign countries, including an attestation based on licenses, inspection reports, certificates, permits, credentials, certification by an appropriate agency (such as a State department of agriculture), or other evidence of oversight.
You do not have to submit records to support this attestation to FDA. But you do need to maintain records that support the attestation, and you must make those records available in the event of an inspection. FDA provides an available online document explaining the attestation process and forms.
If your business is new and not yet registered with FDA, you must submit these attestations prior to starting operations. If you are already a registered facility and want to notify FDA of your QEF status, then you must submit your attestation form by July 31 of the applicable calendar year. Beginning in 2020, you must renew your QEF attestations between October 1 and December 31 of each even-numbered year, in conjunction with your biennial facility registration renewal. For more information about how to register your facility, see the FSMA FAQ ‘Is My Food Business Required to Register with FDA?’
3. What are the consumer notice requirements?
If you make the state law compliance attestation discussed in 2.b.ii above, then you must also disclose to consumers the name and complete business address of the facility where your food was manufactured or processed. This can be done on a product label, a sign at point of sale, any documents arriving along with the food in the normal course of business (i.e. an invoice), or in electronic form for internet sales.
4. Can I lose my QEF status?
FDA and state regulators working with FDA can revoke your qualified exemption if an active investigation of a foodborne illness outbreak is directly linked to your business, or if they think withdrawing your qualified exemption is necessary to prevent or control an outbreak. However, there is a process regulators must follow before withdrawing your exemption, and a chance for you to contest losing QEF status or have it reinstated after being withdrawn.
NOTE: Even if you have a qualified exemption from parts of the PC Rules, you are still at risk for criminal penalties under the Food, Drug and Cosmetic Act if you distribute food contaminated with pathogens. You could also be liable in civil court for the injuries people suffer from eating your contaminated food.
KNOW YOUR RIGHTS: Before FDA can issue an order to withdraw your qualified exemption, it must:
a. Provide you with written notice of the reasons it would use to justify withdrawal of the exemption;
b. Provide you an opportunity to respond within 15 days; and
c. Consider the actions you take to address the food safety concerns FDA identifies as reasons for withdrawing the exemption.
Withdrawing a qualified exemption should be a last resort: FDA can also consider other actions that would address any problem, such as a warning letter, product recall, or product seizure. The FSMA regulations also provide you the ability to challenge the withdrawal or apply to have your exemption reinstated.
IMPORTANT PROTECTION: If FDA takes away your exemption due to an active foodborne illness investigation directly linked to your farm, and then determines that the outbreak wasn’t linked to your farm after all, the agency must automatically reinstate the exemption.
NOTE: If you receive a notice of FDA’s intent to withdraw your qualified exemption, you should seek assistance from legal professionals immediately. The PC Rules include detailed procedures and requirements regarding the process for issuing an exemption withdrawal order, including who must issue the order, what the order must contain, how to appeal it, how to request an informal hearing, when an exemption withdrawal can be revoked, and the process for reinstating the exemption of a qualified facility that was withdrawn.
IF YOUR STATUS IS WITHDRAWN: QEFs that have their exemption withdrawn must come into compliance with the full PC Rule, including Hazard Analysis and Risk-Based Preventive Controls (HARPC) and Supply Chain Program (SCP) requirements. If you don’t appeal the withdrawal, you must achieve compliance within 120 days from receiving FDA’s notice of its intent to withdraw; If you appeal and lose, you have 120 days from the date your appeal is rejected. To learn more about these parts of the PC Rules, see the FSMA FAQ ‘What Are the Basic Requirements of HARPC and SCP?’
1. My business only packs and holds produce, but is not located on a farm and is not majority-owned by a farmer or farmers. Does FSMA apply to my operation?
Your produce packinghouse does not meet the FSMA definitions of a Primary Production Farm or a Secondary Activities Farm (see the FSMA FAQ ‘Is My Food Business a Farm?’), so you need to determine whether your activities holding and packing produce make you a ‘facility’.
Under FDA rules, the term ‘holding’
“means storage of food and also includes activities performed incidental to storage of a food (e.g., activities performed for the safe or effective storage of that food, such as fumigating food during storage, and drying/dehydrating raw agricultural commodities when the drying/dehydrating does not create a distinct commodity (such as drying/dehydrating hay or alfalfa)). Holding also includes activities performed as a practical necessity for the distribution of that food (such as blending of the same raw agricultural commodity and breaking down pallets).”
FDA rules state that ‘packing’
“means placing food into a container other than packaging the food and also includes re-packing and activities performed incidental to packing or re-packing a food (e.g., activities performed for the safe or effective packing or re-packing of that food (such as sorting, culling, grading, and weighing or conveying incidental to packing or re-packing).”
If you are packing and holding produce, your operation can be classified as either a retail food establishment or a food facility.
A retail food establishment is a business that manufactures, packs, or holds food and sells more than half those products directly to consumers, including through on-premises sales, farmers markets, community-supported agriculture, roadside stands, online, mail-order, and other direct marketing platforms. Depending on the kinds of foods and activities, a retail food establishment may be regulated by the state or local health department, or may be subject to ‘cottage food’ regulations if your state has them. FSMA does not apply to retail food establishments.
If less than half of your food sales are directly to consumers, you are likely operating a facility. A facility is required to register with FDA. For more information about food facility registration, see the FSMA FAQ ‘Is My Food Business Required to Register with FDA?’
If your business has to register as a facility with FDA, your produce packing and holding activities are regulated under FSMA’s Preventive Controls Rules for Human Food (PC Rules).
If your operation only packs and holds produce, the PC Rule’s regulations on sanitary operations, known as Good Manufacturing Practices (GMPs), apply to your business. However, FDA has modified these requirements in the case of off-farm produce packinghouse facilities. The PC Rule allows off-farm produce packinghouses to comply with applicable parts of the FSMA Produce Rule instead of the GMPs. Relevant Produce Rule regulations include rules on employee training; worker health and hygiene; sanitation and design of equipment, tools, and buildings; post-harvest handling; and recordkeeping. For an overview of the Produce Rule standards, see the Carolina Farm Stewardship Association’s FSMA FAQ ‘What Are the Basic Requirements of the Produce Rule?’
NOTE ON WASHING PRODUCE: Washing produce is not a ‘packing’ or ‘holding’ activity: FDA considers washing part of ‘processing.’ If you wash any of the produce you handle, you also may have to comply with the PCR regulations on Hazard Analysis and Risk-Based Preventive Controls (HARPC) and Supply-Chain Programs (SCP).
HARPC and SCP are new prevention-oriented food safety requirements added by FSMA. The HARPC and SCP requirements do not apply to your produce packing facility if for 2019, you had 2016-18 average annual sales of crops, livestock products and processed human foods of less than $1,101,1031 (This threshold amount is good for 2019. The dollar thresholds for the qualified exempt and very small business exemptions are to be adjusted for inflation. For more information, see the FSMA FAQ ‘What Are the Special Rules for Qualified Exempt Facilities?’). This is the ‘Qualified Facility’ exemption. Moreover, FDA has stated that it will not enforce HARPC or SCP against facilities like yours, regardless of your revenues, until further notice.
To learn more about the specifics of HARPC and SCP, see the FSMA FAQ ‘What Are the Basic Requirements of HARPC and SCP Under FSMA?’
NOTE: If you meet the Qualified Facility exemption, there are still special preventive control requirements you must meet. For more information see the FSMA FAQ ‘What Are the Special Rules for Qualified Exempt Facilities?’
Training: The PC Rules also require all food-handling employees have the food safety training or experience appropriate to their jobs, and that your food safety plan is created and managed by a Preventive Controls Qualified Individual (PCQI). A PCQI is someone who has completed FDA-authorized training on preventive controls, or who has sufficient job experience to develop and apply preventive controls.
Also, your business may be covered by portions of FSMA’s Sanitary Transportation Rule. To learn more, see the FSMA FAQ ‘Is My Business Covered by the FSMA Rules for Transportation of Food?’
2. Do packinghouses like mine that are on-farm, or majority farm-owned, have to comply with HARPC, SCP, the special Qualified Facility exemptions, and preventive controls training?
No. Produce packing operations that are located on farms, or that are off-farm but majority owned by farmers, are subject to the Produce Rule, not the PC Rule. You may be thinking, and FDA has acknowledged, that is inconsistent to treat produce packing operations differently based on their ownership structure. FDA has pledged to revisit this aspect of the rules and in the meantime has stated that it will not actively enforce the PC Rules against off-farm packing facilities that would be governed by the Produce Rule if they were on a farm or were majority-owned by farmers.
1. I understand that FSMA’s Preventive Controls Rules for Human Food regulates ‘low-risk’ foods differently than other foods. What are ‘low-risk’ foods under FSMA?
Congress included in FSMA a requirement that FDA study different types of food processing, packing, or holding activities applied to various foods to establish if there are combinations of activities and foods that are ‘low-risk’. Congress also said that if FDA identified any such low risk combinations, the agency should exempt small processors located on farms from any Hazard Analysis and Risk-based Preventive Controls (HARPC) requirements under FSMA’s PC Rule.
FDA’s analysis found many food processing and handling activities that, when applied to certain raw materials or processed foods, present a low risk of causing serious adverse health consequences for consumers if the manufacturer fully follows Good Manufacturing Practices (GMPs). In other words, if a business abides by the GMP portions of the PC Rule in its processing or handling activities for those foods, it will automatically control any food safety risks that might be relevant for those foods.
For instance, if you are making and canning jams from high acid fruits, the combination of the acidity of the fruit and the high temperatures necessary to successfully can the jam (i.e. achieve an air-tight seal) will kill any pathogens that might be present in the food before processing.
FDA’s PC Rule provides that an on-farm establishment that only makes or handles foods on FDA’s ‘low-risk’ list, and that meets FDA’s definition of a ‘small’ facility, is exempt from both the HARPC and the Supply Chain Program (SCP) portions of the PC Rule. A ‘small’ facility is one with fewer than 500 employees.
The ‘low-risk’ list is extensive, and covers many of the value-added activities that are commonly performed by start-up local foods businesses and on-farm producers.
2. My business only produces/handles foods on the ‘low-risk’ list, and has fewer than 500 employees, but is not located on a farm. Does the exemption from HARPC and SCP apply to me?
No, the exemptions only apply to on-farm processing, however, they still are important if your small business isn’t on a farm. That’s because the first step for compliance with both the HARPC and SCP portions of the PC Rules is to conduct an analysis of the food safety risks applicable to the foods you handle or make and the processing activities you conduct. In the case of the ‘low-riks’ foods, FDA has already done that analysis for you, and you can rely on FDA’s determination that following GMPs addresses all the relevant risks for those foods.
So you can fulfill your HARPC and SCP requirements by simply (1) documenting that the only foods you make are on the ‘low-risk’ list, citing the FDA’s analysis that there are no hazards or supply chain risks that require additional controls; and (2) abiding by the GMP rules and documentation requirements.
3. What are the GMP requirements for these foods?
To learn more about the essentials of GMPs, see the FSMA FAQ ‘What Are FSMA’s GMP Rules?’
1. My farm meets the criteria for a Qualified Exempt Farm. Does FSMA still apply to me?
Qualified Exempt Farms (QEFs) do not have to comply with FSMA’s regulations that govern growing, harvesting, holding and packing produce. However, there are special requirements for QEFs related to record-keeping, notice to customers, and losing QEF status.
2. What record-keeping requirements apply to Qualified Exempt Farms?
To be Qualified Exempt in 2017, your farm’s 2014-16 average of annual total food sales must be less than $532,645 (see note on inflation adjustment below), and the majority of the value of those sales must be directly to consumers and ‘qualified end-users’. (Qualified end users are restaurants and other retail food establishments, such as roadside stands, CSAs, and direct-to-store sales to grocery stores, located in your same state or within a 275 mile radius of your farm.)
To claim this exemption, you must have records to prove:
a. Your total food sales for each year;
b. The amount of your food sales made directly to consumers each year; and
c. The locations of your non-direct-to-consumer customers. FDA will not require you to prove where your direct-to-consumer customers live, but you will have to document the total value of your annual direct-to-consumer sales.
DEADLINE: You must begin keeping these records for 2016 in order to prove your QEF status starting in 2019. If your farm is less than three years old, FDA will accept records for whatever period of time you’ve been in business.
In addition, you must review your records every year to verify your QEF status, and must start documenting that review in writing in:
- Jan. 2018 if your prior three years’ average annual produce sales are $500,000 or more;
- Jan. 2019 if your prior three years’ average annual produce sales are $250,000 or more; and
- Jan. 2020 if your prior three years’ average annual produce sales are less than $250,000.
These records do not have to be submitted to FDA, but you must keep them and make available upon request by FDA or state food safety agencies.
INFLATION ADJUSTMENT: The total food sales threshold for the qualified exemption is adjusted annually for inflation, with $500,000 in 2011 as the base amount and year. FDA plans to publish the inflation-adjusted benchmark covering the previous three years every March on its website; the average annual total food sales threshold for 2018, which is the earliest possible year for a farm to have to comply with the Produce Rule, will be at least $532,645.
3. What are the customer notice requirements for Qualified Exempt Farms?
PRODUCT LABELS: If you sell any foods that are required by law to have a product label, such as value-added processed foods, that label must also include your farm’s name and business address. QEFs have until Jan. 1, 2020 to implement this labeling requirement.
AT POINT OF SALE: You must provide the name of your farm and your farm business address at the point-of-sale, such as on a sign at a farmers market stand; on an invoice; on an electronic receipt for online sales; and on any label that you affix to a product package. If
- your average annual 2014-16 produce sales are $500,000 or greater in 2017, you should provide this notice beginning in Jan. 2018;
- your average annual produce sales for the prior three years are $250,000 or greater in 2018, you must provide this notice beginning in Jan. 2019;
- your prior 3-year’s average annual produce sales are under $250,000 in 2019, you have until Jan. 2020 to provide this notice.
4. What else can FDA enforce against me as a Qualified Exempt Farm?
FDA and state regulators working with FDA can revoke your qualified exemption if an active investigation of a foodborne illness outbreak is directly linked to your farm, or if they think withdrawing your qualified exemption is necessary to prevent or control an outbreak. However, there is a process regulators must follow before withdrawing your exemption, and a chance for you to contest losing QEF status, or have it reinstated after being withdrawn.
NOTE: Even if you have a qualified exemption from FSMA’s Produce Rule standards, you are still at risk for criminal penalties under the Food, Drug and Cosmetic Act if you distribute food contaminated with pathogens. You are also still liable in civil court for making someone sick with contaminated food. Whether you are qualified exempt or not, knowing the food safety risks on your farm and having a plan for controlling those risks is good business, good farming and the right thing for your customers.
KNOW YOUR RIGHTS: Before FDA can issue an order to withdraw your qualified exemption, it must:
a. Provide you with written notice of the reasons it would use to justify withdrawal of the exemption;
b. Provide you an opportunity to respond, and
c. Consider the actions you take to address the food safety concerns FDA identifies.
Withdrawing a qualified exemption should be a last resort: FDA can also consider other actions that would address any problem, such as a warning letter, product recall, or product seizure. The FSMA regulations set timelines for responding to FDA’s notice of its intent to withdraw, and you have the ability to challenge the withdrawal or have your exemption reinstated.
IMPORTANT PROTECTION: If FDA takes away your exemption due to an active foodborne illness investigation directly linked to your farm, and then it determines that the outbreak wasn’t linked to your farm after all, the agency must automatically reinstate the exemption.
NOTE: If you receive a notice of FDA’s intent to withdraw your qualified exemption, you should seek assistance from legal professionals immediately.
5. What happens if my exemption gets withdrawn?
If FDA or the state farm food safety agency withdraws your qualified exemption, you must come into compliance with the full requirements of the Produce Rule within 120 days. For an overview of the Produce Rule Requirements, see the FSMA FAQ Sheet ‘What are the Basic Requirements of the Produce Rule?’ If you later believe you have grounds for restoring your qualified exemption, you must make a written reinstatement request, including data and information to show that you have resolved any problems, and that denying your QEF status is no longer necessary to protect public health or prevent a foodborne illness outbreak.
