Complying With Food Safety Regulations Under FSMA New Guidelines

  regulations, General, business advice


There are a variety of food safety laws and regulations being enforced in the United States. One of the most important law is the Food Safety Modernization Act (FSMA) which was enacted in 2011. This act requires food businesses that operate both domestic and foreign facilities and manufacture, process, pack, or hold food for human and animal consumption in the US to register with the U.S. Food & Drug Administration(FDA).

On July 14, 2016, the FDA issued a final rule to the regulations on Title 21 Code of Federal Regulations Part 1, Subpart H - Registration of Food Facilities (§§ 1.225 - 1.245). It adds provisions to the FSMA requiring businesses to include additional information when registering facilities. This includes:

  • The contact person of the facility’s email address (domestic facilities)
  • The U.S. agent of the facility’s email address (foreign facilities)
  • The type of activity conducted at the facility for each food product handled

The FDA also amended the definition of the term “retail food establishment”. This was done to expand the number of establishments considered to be “retail food establishments” that are not required to register their food facilities.

On May 2018, the FDA published a new guidance document under the FSMA to reflect these changes. It was created to help small entities (e.g. food and beverage producers) comply with said regulations.

The FDA’s new guideline highlights the importance of food safety by shifting the agency’s focus to prevent contamination rather than the ability to respond to food contamination situations. Furthermore, the requirement of additional information will vastly improve the accuracy of the agency’s food facility registration database. This registration database includes food facilities in the US and in other countries.

The new food safety policy will also help the FDA determine where a food contamination incident originated. As such, the agency can easily notify any facility that might be affected.

Which Businesses Are Affected By This Guidelines?

You have to register your facility if you operate a business that manufactures, processes, packs, or holds any of the following food items:

  • Fruits and vegetables
  • Raw agricultural products used as either food or components for food
  • Fish and other seafood
  • Dairy products and shell eggs
  • Canned and frozen foods
  • Beverages (includes alcohol and bottled water)
  • Bakery goods, snack foods, and candies
  • Infant formula
  • Dietary supplements and dietary ingredients
  • Food for animals (includes pet food, pet treats, and animal feed)
  • Live food animals

If your facilities handle food contact substances or pesticides, you are exempted from registration. The FDA defines food contact substances as substances that are components of materials used in manufacturing, packaging, transporting, or holding food but are not intended to have a technical effect on the food product.

Registering under the FSMA gives the FDA authority to inspect your facilities at any time. Think of the new guidelines as a way for you to help the FDA ensure the food your facility handles is safe for both human and animal consumption.

How To Comply With The New Food Safety Guidelines

Here is everything you need to know about how to comply with the new guidelines.

Facilities That Are Exempt From Registration

As previously mentioned, the final rule expanded on the term “retail food establishment”. You don’t have to register your facility if it falls under any of the following:

  • Private residence even if food is manufactured, processed, or packed in it.
  • Non-bottled drinking water collection facility, distribution element, or structure.
  • Transport vehicle that only holds food as a carrier.
  • Primary production farm or a physical location where crops are grown and harvested, and animals are raised. This can include a location where:
    • Food is manufactured under certain conditions.
    • Raw agricultural commodities are packed and held.
    • Processed foods are packed and held.
  • Secondary production farm or a location which is not a primary production farm but where raw agricultural commodities are harvested, packed, and held (must meet certain ownership criteria to be exempted).
  • Restaurant or a facility that sells food to consumers for immediate consumption.
  • Pet shelter, kennel, and veterinary facility that provides food to animals.
  • Retail food establishment that sells food to consumers as its primary business function. This means that annual food sales to consumers have a dollar value that exceeds the annual food sales to other buyers. This includes:
    • Grocery stores
    • Convenience stores
    • Vending machines
    • Farm operated businesses (a business managed by one or more farms, but food manufacturing and processing are not done on the farm such as roadside stands, door-to-door sales, and online food businesses.)
  • Non-profit food facility such as soup kitchens, central food banks, and free food delivery services.
  • Fishing vessel that does not process fish meaning the vessel harvests, transports, heads, eviscerates and freezes the fish to prepare it only for holding.
  • Facility that is regulated by the US Department of Agriculture (USDA) such as a facility that processes meat, poultry, or egg products inspected by the USDA’s Food Safety and Inspection Service.


As the business owner, you may register your facility. Alternatively, you can also have your facility’s operator, the agent in charge, or any individual duly authorized by any of you may also do so.

If you operate a foreign facility, you must designate a U.S. agent for easy communication with the FDA. The Federal Food, Drug, and Cosmetic Act defines the term “U.S. agent” as a person designated by a foreign facility to register it in the U.S. and act on its behalf for other purposes. The agent must a person physically residing in the USA and maintaining a place of business there. A non-person entity, such as a mailbox or answering machine, cannot be designated as a U.S. agent.

In order to begin manufacturing, processing, packing, or holding food for both human or animal consumption in the US, your facility must first be registered.

A) Registration Process

1. Register, renew, or update your facility by using Form FDA 3537, which is available online or in hardcopy form. To save time, registering online is best.

2. If you do not have Internet access, you can request a copy of the form from the FDA. It can be sent to you either by mail or fax. Fill out the form and then mail or fax it back to the FDA. 


U.S. Food and Drug Administration
Food Facility Registration
5001 Campus Drive
College Park, MD 20740



3. Information required

  • Facility’s name, complete address, and contact number
    • Mailing address (if different from physical address)
    • Parent company name, address, and contact number
    • The email address of the contact person of the facility (domestic)
    • Name, address, phone number, and email address of the US agent of the facility (foreign)
    • Emergency contact number  and email address (only required if different from the contact person)
    • Name, full address, phone number, and email address of the owner, operator, or agent in charge
    • All trade names the facility uses
    • Applicable food product categories (Registration of Food Facilities: What You Need to Know About the FDA Regulation: Guidance for Industry Small Entity Compliance Guide - page 6)
    • Type of activities conducted in the facility for each of its food product categories
    • Assurance that the FDA will be allowed to inspect the facility in accordance with the FD&C Act
    • Certification that all information provided is true and accurate and that the one registering the facility is authorized to do so

4. After you submit the required information, the FDA will confirm your registration, contact you to make the necessary verifications and assign a registration number to your facility.

For U.S. agents, the FDA will need to contact the person to verify that they agreed to serve as your U.S. agent. You, your operators, or agents in charge have 30 days to respond to verification requests from the FDA.

The entire registration process can take up to 60 days.

B) Registration Renewal Or Update

You are required to renew your facility’s registration with the FDA every other year. The date is from October 1 to December 31 of each even-numbered year.

Unless you are updating your information, you are not required to resubmit all your registration information when renewing your facility registration.

To update your registration, visit the FDA’s online forms page or request for the form via fax or mail.

C) Suspension Of Registration

The FDA commissioner (and only the FDA commissioner) has full authority to suspend your facility’s registration in the following cases:

  1. Food manufactured, processed, packed, or held at your facility has a reasonable probability of causing serious health issues or death to humans or animals in the US.
  2. The FDA determined that you or the operator know that food manufactured, processed, packed, or held in the facility could cause serious health issues or death to humans or animals.

If your facility is suspended, it can neither import nor export food. Additionally, if you operate within a certain U.S. state, you cannot sell food within or outside that state.

D) Failure To Register

There is no fee for registering your facilities or renewing or updating your registration. This means there is no reason not to do it. Refusal to register your facility will only damage your business. The FDA may seize your food products and hold them until you register your facility. You could also end up facing either civil or criminal charges from the government

Use Inventory Management Software To Help You Comply With Regulations

food tracking

The FSMA mandates that all food businesses must have a proper traceability system in place. This system ensures that your business can easily identify the location of a food product in the event of a contamination.

To achieve this, you need to integrate an inventory management software into your food safety plan. Doing so can help your business to gain increased control and visibility over your inventory throughout the supply chain. Furthermore, it will also allow you to access real-time inventory data at any time.

With inventory management software, it would be easy for you to pinpoint the current location of a product, wherever it might be in the supply chain. This is useful in the event of doing a product recall. Initiating an effective recall will not only help you comply with regulations but also maintain public health by preventing the consumption of contaminated food.


Need an effective food traceability system for your business? Sweet’s inventory management software is the perfect tool for you. It can help you streamline and automate your inventory processes. But most of all, it can help you meet legal regulations and guarantee the safety of your food products

To find out how Sweet can help you, request a free demo today.

Looking For Help To Track Your Inventory?

Save time and money by signing up for a free trial of Sweet today!