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Webinar Highlights

On-Farm Requirements

Where does your farm fall under the FSMA Produce Safety Rule?

Farms can fall into one of three categories: covered farms, farms eligible for qualified exemption & modified requirements or the farm is not covered under the Produce Safety Rule.

1. Covered Farms -  more than $638,491 in annual food sales for last 3 years AND most sales are not to end consumer.

   Covered small farms - annual food sales for last 3 years falls between$250,000-$638,491

   Covered very small farms - annual food sales for last 3 years falls between ($31,925-$250,000)

2. Farms eligible for qualified exemption & modified requirements have average food sales under $638,491 for the last three years AND the majority of food sales must be made to Qualified End Users (QEU) during that time frame.
3. Farms not covered by the Produce Safety Rule average less than $31,925 in produce sales for last 3 years AND the majority of food sales must be made to Qualified End Users (QEU) during that time frame.

Qualified End Users are the consumer of the food (regardless of location) and include your farm, farmers market, CSA  and/or via internet sales. Restaurants and grocery stores (that you deliver to directly) within 275 miles of your farm

NC State Extension has created a worksheet that will help guide you through determining your farm's status.

Exemptions to the Produce Safety Rule

•  Farms that only grow rarely consumed raw produce. These are fruits and vegetables that are almost always cooked before being consumed.
• Farms that only grow produce that will be commercially processed and in which there will be a kill step.
  • If exempt from the Produce Safety Rule, you are still fully liable for growing safe produce under the Federal Food, Drug & Cosmetic Act.

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FDA Food Facility Requirements

What is an FDA Food Facility? 

A food facility is any establishment, in one physical location or mobile, that manufactures, processes, packs and/or holds foods for human consumption. Also applies to multiple company entities processing at a shared facility.

Why do I need to register my food facility?

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) directs the Food and Drug Administration (FDA), to take steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply and other food-related emergencies. These emergencies could include your product, or ingredients of your product, being identified in an outbreak or recall event.

Food Facility Registration Basics

1. There is no cost to register, renew or update food facility registrations.
2. Each facility location must gain a unique facility identifier (UFI). Dun & Bradstreet is currently the only acceptable source of a UFI, this service is also free of charge.
3. Companies will also need to include their facility name, address or location, activity types and food product categories (if they are manufacturing or processing food).

FDA Food Facility Activity Types

Food Product Categories

and Fruit Products
Fruit or Vegetable Juice, Pulp or Concentrate Products
Nuts and Edible Seed Product Categories: Nut and Nut Products; Edible Seed and Edible Seed Products
Shell Egg and Egg Product Categories: Chicken Egg and Egg Products; Other Egg and Egg Products

Vegetable and Vegetable Product Categories: Fresh Cut Products; Raw AgriculturalCommodities; Other Vegetable and Vegetable Products
Grain or Grain Products (i.e., barley, grain sorghums, maize, oat, rice, rye, wheat, other grains or grain products)
Oilseed or Oilseed Products (i.e., cottonseed, soybeans, other oilseeds or oilseed products)
Alfalfa Products or Lespedeza Products

Milk Products Citrus Products Miscellaneous or Special Purpose Products Processed Animal Waste Products
Animal By-Products and Extracts Distillery Products Molasses or Molasses Products Technical Additives
Amino Acids or Related Products Fats or Oils Marine Products Vitamins or Vitamin Products
Animal Protein Products Enzymes Peanut Products Yeast Products
Botanicals and Herbs Herbals and Botanicals Fermentation Products Minerals or Mineral Products
Chemical Preservatives Forage Products Brewer Products Human food by-products not otherwise listed*

Qualified Facility Attestation

The FDA provides qualifications for smaller businesses that lift some requirements of 21 CFR 117. Qualified facilities are only subject to subparts A, B & F.

Subpart A -  General Provisions

Subpart B - Current Good Manufacturing Practices for Human Foods

Subpart F - Records

Companies must file their attestation with the FDA and keep records to prove revenue. Determining if you're qualified facility can be calculated using tax forms (IRS Form 1120), accounting documents, and/or invoices and bills of lading.

Important Registration Dates & Timelines

AND

Submit form FDA 3942a when renewing FDA Facility Registration biannually

If no longer a Qualified Facility, must submit an FDA Form 3942a by the end of July

Exemptions from Registering as a Food Facility

* When the majority of product sold is to the consumer (not wholesale) ** When the vessel is not processing seafood onboard

NC Licenses for FDA-regulated Food Facilities

NCDA&CS’s Food Program required licensing for the following industries*:

–Grade A milk operation (permit)

–Milk haulers & testers

–Cheese and butter processors

–Frozen dessert manufacturers

*List excludes any type of business or commerce-based licenses like a NC business license or Tax ID

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Retail Food Variance Requirements

Retail food establishments, including restaurants, buffets, caterers and other food service establishments, at times, want to produce foods that are either high-risk or outside of the typical parameters for food safety, as outlined in the NC Food Code. The North Carolina Department of Health and Human Services has identified many of these high-risk items and has created a system that allows their production. This system includes a written application, review and implementation processes required for companies engaging in high-risk processing (note flow charts further in this post).

"Variance" means a written document issued by the regulatory authority that authorizes a modification or waiver of one or more requirements of this Code if, in the opinion of the regulatory authority, a health hazard or nuisance will not result from the modification or waiver.” 

Variances in North Carolina require a Hazard Analysis and Critical Control Points (HACCP) plan. HACCP plans are a systematic, hazard-based system that ensures risks are controlled in the processing of food items. These plans shows the processing of foods is equal in safety to what is already allowed in the NC Food Code Manual.  Lastly, HACCP plans are specific to the product, processing and facility.

Identified Special Processes

View NC DHHS's full list of identified products requiring additional food safety considerations.

View NC DHHS'S variance decision tree flow chart.

More examples of when a variance is required:

1. Smoking food for food preservation rather than a method of flavor enhancement;

2. Curing food;

3. Using food additives or adding components such as vinegar to address pH:

• As a method of food preservation rather than as a method of flavor enhancement; or
• To render a food so that it is not potentially hazardous (Time/Temperature Control of Safety Food);

4. Packaging food using a ROP method except as specified under Section 3-502.12;

5. Operating a molluscan shellfish life-support system display tank used to store or display shellfish offered for human consumption;

6. Custom processing animals for personal use (not for sale/service in a Food Establishment);

7. Preparing food by another method that is determined to require a variance; or

8. Sprouting seeds or beans.

Examples of when a HACCP plan, but not a variance is required:

1. A TCS food that is packaged using reduced-oxygen packaging (ROP) method, maintained at 41°F or less and meets at least one of the following criteria:

• Has a water activity (A_w) of 0.91 or less;
• Has a pH of 4.6 or less;
• Is a meat or poultry product cured at a food processing plant regulated by the NCDA&CS Meat & Poultry Inspection Division or USDA; or
• Is a food with a high level of competing organisms, such as raw meat, poultry or vegetables.

2. Fish that is frozen before, during, and after packaging using a ROP method (3-502.12)

3. Food that is prepared and packaged using a cook-chill or sous vide method (3-502.12);

4. Specific cheeses that are packaged using a ROP method (3-502.12);

5. Juice packaged in a food establishment without a warning label (3-404.11);

6. Unpackaged juice prepared in a food establishment serving a highly susceptible population (3-801.11)

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Contact our Speakers:

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Webinar hosted on May 17, 2024

“This work was supported by the intramural research program of the U.S. Department of Agriculture, National Institute of Food and Agriculture, Food Safety Outreach Program 1030908. The findings and conclusions in this preliminary publication have not been formally disseminated by the US Department of Agriculture and should not be construed to represent any agency determination or policy.”