Food Safety

THERE ARE 5 MAJOR ELEMENTS

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. For the first time, 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.

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 3-day PCQI class or possess equivalent knowledge based on experience as approved by FDA. Fortunately, MMEC has a Lead trainer on staff and periodically offers PCQI classes as regularly scheduled events or in response to requests. Please check 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 Program. 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 at the FDA’s Frequently Asked Questions on FSMA website.

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

There are modified requirements for very small businesses, defined as those businesses (including any subsidiaries or affiliates) averaging less than $1,000,000 (adjusted for inflation) in both sales of human food plus the market value of human food that is manufactured, processed, packed, or held without sale (e.g. held for a fee), per year during the 3-year period preceding the current calendar year.  These "qualified" facilities still need to comply with FSMA subparts B and F, but can submit an attestation to the FDA during the same two year timeframe that the facility is required to update its facility registration to exempt them from the Preventive Controls Qualified Individual (PCQI) requirement.  This is the bare minimum federal requirement, but those companies are still encouraged to complete a PCQI course to assure safe food for consumers.  For more information on small entity compliance, see the FDA's Small Entity Compliance Guide.

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

NOW!  All compliance dates have passed:

* Large: Cert. Date – 8/30/16

* Small (< 500 employees): Cert. Date – 8/30/2017

* Very Small (< $1M food sales): Cert. Date – 9/30/2018

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

a. No. Your industry is overseen by the Alcohol and Tobacco Tax and Trade Bureay (TTB), rather than the FDA. But FSMA has some requirements for Animal Feed if that’s what you do with spent grain. 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.

Breweries and distilleries, although technically exempt from a HACCP Plan and PCQI requirement, need to follow Current Good Manufacturing Practices (cGMP) and Record Keeping.

a. Always remember: Are you required to register your facility with the FDA? Therefore, 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.

i. HACCP training is not required unless you are in one of the manufacturing categories listed above.

ii. 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.

Read more about the FSMA Final Rule for Preventive Controls for Human Food

See the FDA website on the Food Safety Modernization Act