What does FSMA stand for?

FSMA stands for The Food Safety Modernization Act (FSMA), a sweeping federal law passed in 2011 that enforces many new standards on food manufacturers to help prevent foodborne illnesses and prevent contamination.

What is FSMA compliance?

There are two separate levels of FSMA certification for compliance:

  • Government Compliance – rules and regulations required by the FDA, USDA and state/local requirements
  • Commercial Compliance – requirements put forth by a client or purchaser on a manufacturer. Commercial compliance is at multiple levels and requires a third-party audit from companies such as NSF, ABI, or other certification bodies under the Global Food Safety Initiative (GFSI) such as SQF as BRC.

What is FSMA?

There are five major elements to FSMA:

Preventive Controls. FDA now has the mandate to require comprehensive, prevention-based controls across the food supply.

Inspection and Compliance. The legislation recognizes that inspection is an important means of holding industry accountable for its responsibility to produce safe food. FDA is committed to applying its inspection resources in a risk-based manner and adopting innovative inspection approaches.

Imported Food Safety. FDA has new tools to ensure that imported foods meet U.S. standards and are safe for our consumers. For example, for the first time, importers must verify that their foreign suppliers have adequate preventive controls in place to ensure safety, and FDA will be able to accredit qualified third-party auditors to certify that foreign food facilities are complying with U.S. food safety standards.

Response. FDA has mandatory recall authority for all food products. The agency has other new authorities that are also in effect: expanded administrative detention of products that are potentially in violation of the law, and suspension of a food facility’s registration.

Enhanced Partnerships. The legislation recognizes the importance of strengthening existing collaboration among all food safety agencies—U.S. federal, state, local, territorial, tribal and foreign–to achieve our public health goals. For example, it directs FDA to improve training of state, local, territorial and tribal food safety officials.

What are the Seven Foundational Rules in the FSMA?

Preventive Controls for Human Food. Requires that food facilities have safety plans that set forth how they will identify and minimize hazards. Also, REQUIRES that a Preventive Controls Qualified Individual prepares and verifies the facility food safety plan. That person must successfully complete a 20-hour PCQI class or possess equivalent knowledge based on experience as approved by FDA. Fortunately, Impact Washington has a Lead trainer on staff and periodically offers PCQI classes as regularly scheduled events or in response to requests. Please check our events section of our website for upcoming classes or contact us if you are interested in scheduling a class.

Preventive Controls for Animal Food. Establishes Current Good Manufacturing Practices and preventive controls for food for animals.

Produce Safety. Establishes science-based standards for growing, harvesting, packing and holding produce on domestic and foreign farms.

Foreign Supplier Verification Programs. Importers will be required to verify that food imported into the United States has been produced in a manner that provides the same level of public health protection as that required of U.S. food producers.

Third Party Certification. Establishes a program for the accreditation of third-party auditors to conduct food safety audits and issue certifications of foreign facilities producing food for humans or animals.

Food Defense (intentional adulteration). Requires domestic and foreign facilities to address vulnerable processes in their operations to prevent acts intended to cause large-scale public harm.

Sanitary Transportation. Requires those who transport food to use sanitary practices to ensure the safety of food.

More information can be found on the FDA’s FAQ webpage

Do I need to comply with FSMA?

The short answer is if you have to register with the FDA as a food manufacturing facility, yes.

Do I have to register with the FDA?

If you manufacture, process, pack or hold food in the USA, yes.

Do I need an HACCP Plan?

If you process Meat & Poultry (USDA), Juice (FDA) or Seafood (FDA / USDA), yes, you are required to have an HACCP Plan.

For anybody else, not legally. But you will need a Preventive Controls Plan under FSMA, and the start of that is an HACCP Plan. So for all practical purposes, yes you do.

Does Impact Washington offer any assistance for training fees?

Yes. If you are a USDA Specialty Crop producer or processor, you may qualify for discounted HACCP or PCQI training. USDA Specialty Crop definitions are here.

Below are the criteria for determining a Specialty Crop discount, if any.

  1. If you use less than 5% in pounds or dollars of Specialty Crops in your operation you get NO discount.
  2. If you use between 5% and 50% of Specialty Crops in your operation in either pounds or dollars, you will receive a 50% discount.
  3. More than 50% in either pounds or dollars, the class is no charge, although we will charge for incidentals like lunch and a manual.

I’m a brewery/distillery, do I need a HACCP/PCQI Plan?

No, but you still need to comply with 21 CFR 117 subpart A, B and F which includes current Good Manufacturing Practices (cGMPs) and Record Keeping. Your industry is overseen by the TTB, rather than the FDA. FSMA also has some requirements for Animal Feed if that’s what you do with spent grain or fruit. Additionally, FSMA has a provision for TTB to invite FDA to inspect any establishment under their jurisdiction in the event of a significant consumer complaint.

Do meat packing plants need to comply with FSMA?

No. USDA already requires HACCP. FSMA is only for facilities with FDA oversight.

Do restaurants need to comply with FSMA?

Retail food sales are NOT regulated by the FDA. Nor are Farmers’ Markets. Or soup kitchens. Or hot dog stands at baseball games. But interestingly, the wild game raised and harvested for sale IS regulated by the FDA.

Can I use Incumbent Workers Training (IWT) funds to pay for this class?

Possibly. Please contact IWT for more information.

There are two points to consider:

  • HACCP training is not required unless you are in one of the manufacturing categories listed above.
  • You also are not required to have an employee(s) as your Preventive Controls Qualified Individual. A consultant or other outside person COULD be your PCQI, so long as they have been trained and perform all the duties FSMA requires of a PCQI.

Where can I learn more about the requirements?