Food Safety Modernization Act

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Nearly 1 in 6 Americans get sick from foodborne illnesses every year. Approximately 3,000 die each year. The Food Safety Modernization Act (FSMA) is intended to significantly reduce these mostly preventable occurrences in the food manufacturing industry. The FSMA is a sweeping law which was passed in 2010 and has given the FDA great responsibilities and enhanced jurisdiction. The FDA has worked with industry, manufacturers, trade groups, and the general public to publish a series of Rules which have the full effect of law. As these Rules have become published they have been set with deadlines for compliance. Exacting attention will be paid to risk and risk reduction throughout the processing steps. The goal is to identify all the possible ways in which food might become adulterated or rendered unsafe, and establish and adhere to control steps that mitigate those risks. The FSMA is law, signed by the President of the United States. Violations may be treated as criminal acts. 

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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.

Compliance with these new rules will be phased in depending on company size.

  • Largecompanies with more than 500 employees need to achieve compliance in 2016.
  • Smallbusinesses with less than 500 employees are due in 2017. 
  • Very smallbusinesses are defined with different sales levels depending on which rule, but for the Preventive Controls rule, they are defined as having sales less than $1,000,000 annually.
  • The GMA has provided a reference sheet for Compliance Dates. It can be found here.
  • More information can be found at the FDA’s FAQ here

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

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

 a. It means that you have had a Preventive Controls Qualified Individual prepare and oversee your food safety plan.
 a. If you process Meat & Poultry (USDA), Juice (FDA), Seafood (USDA), or Dairy (USDA) you are required.

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. 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.

b. 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.

a. No. Your industry is overseen by the 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.
a. No. USDA already requires HACCP. FSMA is only for facilities with FDA oversight.

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.

a. Possibly. Please contact IWT for more information.

b. There are two points to consider:

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.

a. Preventive Controls for Human Food link is HERE

b. The entire Food Safety Modernization Act is HERE

Other Considerations

Every manufacturer covered by FSMA will have to comply with some parts of the law. Some manufacturers may have to comply with most or all of the law. The Preventive Controls for Human Food Rule will probably have the biggest impact on most manufacturers, and as such, is considered the backbone of FSMA.

If you have a Hazard Analysis and Critical Control Points (HACCP) plan you are part-way to compliance with the Preventive Controls Rule, but you are NOT compliant. The Preventive Controls for Human Food Rule will require your HACCP Plan to be updated and enhanced. If you do NOT have a HACCP Plan, the MMEC strongly recommends that you put one in place immediately. It will serve as the backbone for your Preventive Controls Food Safety Plan.

Implementing HACCP is an intense and time-consuming process. Implementing Preventive Controls is even more time-consuming. It is important that you start early.

The Montana Manufacturing Extension Center with assistance from the Montana Department of Agriculture is carefully monitoring the requirements of FSMA as they come online and are clarified and is providing training and expertise to those food manufacturers who desire it. MMEC is providing PCQI classes and certification, along with HACCP training. Mr. Claude Smith is the Food and Process Specialist for the MMEC and he brings more than 30 years of food manufacturing experience to this important role. Claude is an expert on HACCP and is a FSPCA (Food Safety Preventive Controls Alliance) Lead Instructor in Preventive Controls for Human Food. Check our website for new classes as they are offered, or contact us to schedule a class.


Montana Department of Agriculture Survey

  • Help farmers estimate if they’re covered or exempt from the Produce Safety Rule
  • Help the Department determine how many covered farms there may be in Montana
  • Identify areas of need for outreach and education.

University of Arkansas Survey

  • FDA Grant to provide Native American outreach, training, technical assistance and education around FSMA
  • Assessment to gather input and determine priorities
  • Questions and more information on Indigenous food and agriculture HERE

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