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U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES U.S. FOOD AND DRUG ADMINISTRATION

SMALL BUSINESS UNDER THE PC HUMAN FOOD RULE

Certain facilities that are very small businesses or small (or very small) farm mixedtype facilities may be exempt from or subject to modified requirements regarding the 

preventive controls requirements of the Preventive Controls (PC) for Human Food Rule, 

one of the FDA Food Safety Modernization Act (FSMA) foundational rules. 

Does that include your facility or farm mixed-type facility? This fact sheet will help 

answer that question.

¢ What are a “small business” and “very small business”?

A “small business” is a business, including any affiliates and subsidiaries, employing fewer than 

500 full-time equivalent employees. 

A very small business is a business (including any subsidiaries or affiliates) that averages less 

than $1,000,000 (adjusted for inflation) in sales of human food plus the market value of human 

food that is manufactured, processed, packed, or held without sale (for example, held for a 

fee), per year during the previous three-year period. For current values adjusted for inflation, 

see “FSMA Inflation Adjusted Cutoffs” at: https://www.fda.gov/food/guidanceregulation/fsma/

ucm554484.htm

¢ Who is subject to the preventive controls requirements in the PC Human Food Rule?

Generally, domestic and foreign human food facilities that are required to register with FDA 

under the Federal Food, Drug, & Cosmetic Act are required to comply with the preventive controls 

requirements in the PC Human Food Rule, entitled Current Good Manufacturing Practice, Hazard 

Analysis, and Risk-Based Preventive Controls for Human Food. Note that applicability of the 

Current Good Manufacturing Practices (CGMP) requirements is determined separately and is not 

based on registration.

¢ Who is not subject to the preventive controls requirements in the PC Human Food Rule?

Certain establishments are exempt from the PC Human Food Rule because they do not 

have to register with FDA. These include farms, restaurants (including cafeterias, fast 

food establishments, catering facilities, and hospital kitchens), retail food establishments 

(including grocery stores, convenience stores, and vending machine locations), nonprofit food 

establishments, and establishments that process only meat, poultry, and egg products that are 

inspected by the U.S. Department of Agriculture.

IF YOUR FACILITY IS A VERY SMALL BUSINESS OR A SMALL (OR 

VERY SMALL) FARM MIXED-TYPE FACILITY, WHAT PC HUMAN FOOD 

EXEMPTIONS/MODIFIED REQUIREMENTS APPLY TO YOU?
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U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES U.S. FOOD AND DRUG ADMINISTRATION

SMALL BUSINESS UNDER THE PC HUMAN FOOD RULE

Even if you are required to register with FDA as a food facility, there may be other situations 

in which your facility is eligible for an exemption, subject to modified requirements, or subject 

to enforcement discretion, regardless of the size of the business. For more information, see 

Guidance for Industry: What You Need to Know About the FDA Regulation: Current Good 

Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; 

Small Entity Compliance Guide and Enforcement Discretion Policy for certain FSMA Regulations.

¢ Can a facility be exempt from the preventive controls requirements of the PC Human Food 

Rule based on its size?

Yes, a facility may qualify for an exemption from the preventive controls requirements of the PC 

Human Food Rule if it meets certain criteria related to the size of the business that would make 

the facility a “qualified facility,” e.g., it is a “very small business.” For requirements applicable to 

qualified facilities, see the question “What modified requirements apply to qualified facilities?” on 

page 3 of this fact sheet. 

You may also qualify for an exemption from the PC requirements based on size if your facility is 

a farm mixed-type facility that is a small or very small business, and you conduct only certain 

low-risk activities on specified human food. A “farm mixed-type facility,” is an establishment that 

is a farm that would otherwise meet an exemption from registration except that it also conducts 

activities outside the farm definition that require the establishment to be registered. For more 

information about this exemption, see the section titled “Exemption for On-Farm Low-Risk 

Activities Conducted by Facilities That Are Small or Very Small Businesses” on page 4 of this 

fact sheet. 

¢ What exemption from preventive controls requirements is applicable to some small and 

very small farm mixed-type facilities?

If a facility is a farm mixed-type facility that is a small or very small business, and it conducts 

only certain low-risk activities on specified human food, it is entirely exempt from the preventive 

controls requirements. For more information about this exemption, see “Exemption for On-Farm 

Low-Risk Activities Conducted by Facilities That Are Small or Very Small Businesses” on page 4 

of this fact sheet. 

¢ Have compliance dates or enforcement policy changed since FDA published the PC Human 

Food Rule?

Yes, for some facilities. In a final rule published in August 2016, FDA extended the compliance 

dates for the PC Human Food Rule for certain facilities to address concerns about the practicality 

of compliance with certain provisions, consider changes to the regulatory text, and better align 

compliance dates across the rules. Note that the extended compliance dates have passed for 

facilities that are neither small nor very small businesses. In January 2018, FDA published 

guidance indicating its intent to exercise enforcement discretion from all or part of the PC Human 

Food Rule in certain circumstances related to the “farm” definition (see Guidance for Industry: 

Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and 

Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs). 
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U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES U.S. FOOD AND DRUG ADMINISTRATION

SMALL BUSINESS UNDER THE PC HUMAN FOOD RULE

Qualified Facilities

¢ What is a qualified facility?

A qualified facility is either (1) a “very small business” or (2) a business (including any subsidiaries 

or affiliates) whose average annual monetary value of the food sold during the previous threeyear period was less than $500,000 (adjusted for inflation) and whose average annual monetary 

value of food manufactured, processed, packed or held and sold directly to consumers, retailers, 

and restaurants within the same state or the same Indian reservation or within 275 miles of the 

facility was more than the monetary value of food sold by the facility to other purchasers. FDA 

anticipates that most “qualified facilities” will be ones that meet the definition of “very small business.” 

¢ What modified requirements apply to qualified facilities?

A qualified facility is required to submit Form FDA 3942a, attesting to its qualified facility status 

(meaning that the facility meets the financial requirements to be a qualify facility) and attesting 

that it is either:

1. Addressing identified hazards through preventive controls and monitoring 

the preventive controls; or

2. Complying with applicable non-federal food safety law (including state 

food safety laws), and notifying consumers of the name and complete 

business address of the facility where the food was manufactured 

or processed.

A qualified facility is also required to maintain the records they rely upon to support the 

attestations they make on Form FDA 3942a. In addition, qualified facilities are required to comply 

with the Current Good Manufacturing Practice requirements.

¢ How do I send my Form FDA 3942a to FDA?

The form can be submitted in two ways:

§ Electronically — Log into your FDA Industry Systems account at 

http://www.fda.gov/furls and follow the instructions. FDA encourages 

electronic submission.

§ Mail — Send a completed paper Form FDA 3942a to the U.S. Food and 

Drug Administration (HFS-681), 5001 Campus Drive, College Park, MD 

20740. We recommend that you submit a paper copy only if your facility 

does not have reasonable access to the Internet. 

• The form can be downloaded from: 

https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM620461.pdf

Alternatively, you can request a copy of the form by writing to the U.S. Food and Drug 

Administration (HFS-681), 5001 Campus Drive, College Park, MD 20740, or calling 

1-800-216-7331 or 301-575-0156.

Additional information on how to submit Form FDA 3942a can be found in the guidance entitled 

“Qualified Facility Attestation Using Form FDA 3942a (for Human Food) or Form FDA 3942b (for 

Animal Food): Instructions for Submitting your Attestation.”
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U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES U.S. FOOD AND DRUG ADMINISTRATION

SMALL BUSINESS UNDER THE PC HUMAN FOOD RULE

¢ What compliance dates apply to my qualified facility? And when do I have to tell FDA that 

my facility is a qualified facility?

Qualified facilities had to comply with the modified requirements for qualified facilities and with 

CGMP requirements by September 17, 2018. In addition, a qualified facility must retain records to 

support its status as a qualified facility starting January 1, 2016.

The attestation form (Form FDA 3942a) stating that your facility is a qualified facility must be 

submitted to FDA initially:

§ By December 17, 2018, for a facility that begins manufacturing, 

processing, packing or holding food before September 17, 2018, or 

§ Before beginning operations, for a facility that begins manufacturing, 

processing, packing or holding food after September 17, 2018.

Beginning in 2020, your attestation must be submitted to FDA every two years between October 1 

and December 31. 

Your determination of whether your facility meets the definition of a qualified facility must be 

made no later than July 1 of each calendar year. 

Exemption for On-Farm Low-Risk Activities Conducted by Facilities That Are 

Small or Very Small Businesses

¢ What exemption for on-farm low-risk activities might apply to a farm mixed-type facility 

that is a small or very small business?

If a facility is a farm mixed-type facility that is a small or very small business, and the only 

activities that the non-farm part of the facility conducts are certain low-risk activities on specified 

human food, the facility is entirely exempt from the preventive controls requirements but is still 

subject to the CGMP requirements. 

If the non-farm part of a farm mixed-type facility is engaged in activities other than the specified 

low-risk activities, but it meets the definition of a qualified facility, then the facility must follow the 

modified requirements applicable to qualified facilities, including submitting a Form FDA 3942a.

¢ What are some of those low-risk activities exempt from the preventive controls 

requirements in some circumstances?

Certain low-risk activities on certain human foods are not subject to the requirements for hazard 

analysis or risk-based preventive controls, or to the modified requirements, if the activities 

are conducted on farms by farm-mixed type facilities that are small or very small businesses, 

and if these are the only activities they conduct that would be subject to hazard analysis and 

preventive controls or the modified requirements. The activities include packing and holding or 

manufacturing/processing certain human foods. 

Some examples of the types of foods and activities that might receive an exemption are:

§ Packing baked goods, candy, or preserves

§ Storing pasteurized honey
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U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES U.S. FOOD AND DRUG ADMINISTRATION

SMALL BUSINESS UNDER THE PC HUMAN FOOD RULE

§ Packing trail mix and granola

§ Boiling gums, latexes and resins

§ Slicing bread

§ Cutting lemons or limes

§ Coating raisins with chocolate

§ Grinding coffee beans 

§ Making potato chips

This is not an exhaustive list of foods and activities that may qualify for an exemption. See the 

PC Human Food Small Entity Compliance Guide for more details on the exemptions for on-farm 

low-risk activities conducted by small and very small businesses. 

¢ For More Information

§ Determination of Status as a Qualified Facility in the PC Human Food Rule 

and PC Animal Food Rule: Guidance for Industry

§ Qualified Facility Attestation Using Form FDA 3942a (for Human Food) 

or Form FDA 3942b (for Animal Food): Instructions for Submitting 

Your Attestation

§ Qualified Facility Attestation

§ Form FDA 3942a: Qualified Facility Attestation for Human Food Facilities

§ Guidance for Industry: What You Need to Know About the FDA Regulation: 

Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based 

Preventive Controls for Human Food: Small Entity Compliance Guide

§ FSMA Inflation Adjusted Cut Offs

§ Draft Guidance for Industry: Determining the Number of Employees for 

Purposes of the “Small Business” definition in Parts 117 and 507

§ Final Rule; Extension and Clarification of Compliance Dates for 

Certain Provisions

§ Policy Regarding Certain Entities Subject to the Current Good 

Manufacturing Practice and Preventive Controls, Produce Safety, and/or 

Foreign Supplier Verification Programs: Guidance for Industry