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FSMA Overview: A Look at The FDA’s Seven Major Rules

President Obama signed FSMA, Food Safety Modernization Act, into law January 4th, 2011. It's considered the most sweeping reform of food safety laws in more over 70 years. The Act was put into motion to ensure that U.S. food, for both humans and animals, are safe for consumption by focusing on preventing vs. reacting to contamination. The responsibility of course falls on the shoulders of the food manufacturers, and the FDA has published 7 major rules under FSMA. Here's a recap of them with special thanks to FDA-News.RegistrarCorp.com.

Food Manufacturers and Automating Quality Management through ERP Systems

We can all agree that prevention is much better than reaction, especially when considering the health of the public. That doesn't mean it has to break the bank, however, or cause food manufacturers to hire more staff. It requires smart business practices and lean manufacturing processes. Food manufacturers can use ERP systems to help keep track, show proof, and stay in compliance with the FSMA FDA rules. Through process automation, centralized documentation, and quality management processes completed right in your ERP system makes following these rules a simple process vs. a serious headache.

Rule 1: Preventive Controls Rules for Human and Animal Food

Compliance Dates:

  • Very-small businesses (businesses that have less than $1,000,000 in total annual sales of human food, adjusted for inflation): September 2018
  • Businesses subject to the Pasteurized Milk Ordinance: September 2018
  • Small businesses (businesses with fewer than 500 full-time equivalent employees): September 2017
  • All other businesses: September 2016

The FDA’s Preventive Controls Rules apply to all facilities required to register with the FDA as a food facility, unless covered by an exemption (See page 19 of the final rule for a complete list of exemptions). A covered facility must implement a written Food Safety Plan that identifies known or reasonably foreseeable biological, chemical, and physical hazards related to foods in the facility. For each identified hazard, the Food Safety Plan must determine whether the hazard requires preventive controls and, if so, outline preventive controls to minimize or prevent that hazard.

While similar to other food safety programs, such as HACCP, ISO 22000, or BRC, these plans do not satisfy the requirement of having an FDA Food Safety Plan. A Preventive Controls Qualified Individual (QI) must create or oversee the development of a facility’s Food Safety Plan. The Preventive Controls Qualified Individual may or may not be an employee of the facility.

The Preventive Controls Rules also require covered facilities to approve their raw material and ingredient suppliers when the receiving facility has identified a hazard requiring a preventive control. In approving suppliers, facilities must consider multiple factors, including the supplier’s performance (i.e., compliance with FDA regulations, including FDA warning letters, Import Alerts, etc). Facilities can use the FDA’s public databases or a third-party tool to monitor a supplier’s status.

Rule 2: Produce Safety Rule

Compliance Dates: Compliance dates for the FDA’s Produce Safety rule depend on a business’s size, exemption status, and whether or not the business deals with sprouts. Click here for more information on Produce Safety compliance dates.

The FDA’s Produce Safety Rule establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce. The rule puts more responsibility on farms to protect their crops from contamination by creating requirements for water quality testing, raw manure application, examining grazing areas, employee health and hygiene training, and more. The rule gives special attention to sprouts due to their frequent association with foodborne illness outbreaks

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Rule 3: Foreign Supplier Verification Program (FSVP) Rule

Compliance Dates:

The latest of the following dates:

  • 18 Months after publication of the final rule  (May 2017)
  • For the importation of food from a supplier that is subject to the preventive controls or produce safety rules: six months after the foreign supplier is required to meet the relevant regulations.
  • For an importer that is itself a manufacturer or processor subject to the supply-chain program provisions in the preventive controls regulations: the date by which it has to comply with those provisions.

The FSVP rule requires importers to verify their foreign suppliers are producing food in compliance with applicable FDA regulatory requirements. To approve a supplier, an importer must evaluate the risks posed by foods it supplies by determining potential hazards associated with each food, as well as by evaluating the supplier’s performance (i.e., FDA compliance history). Importers must then implement an FSVP for each approved supplier and each food imported from that supplier. The rule gives importers the flexibility to choose appropriate verification activities for each food and supplier. Examples of potential verification activities include annual onsite audits of a supplier’s facility, sampling and testing a supplier’s products, or reviewing a supplier’s food safety records.

The FDA defines an importer as “the U.S. owner or consignee of a food offered for import into the United States” for purposes of this rule. If there is no U.S. owner or consignee, the FDA considers the U.S. agency or representative of the foreign owner of consignee at the time of entry to be the importer

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Rule 4: Accredited Third-Party Certification

Compliance Dates:N/A (Voluntary)

The Third-Party Certification rule established a voluntary program for the accreditation of third-party certification bodies to conduct food safety audits and issue certifications of foreign facilities and the foods they produce. Under the program, the FDA recognizes what are called accreditation bodies, which then may accredit third-party certification bodies.

Accredited third-party certification bodies can perform two types of audits: consultative and regulatory. A consultative audit is conducted in preparation for a regulatory audit, while a regulatory audit is the basis for certification. Foreign facilities can use certification from a Third-Party Certification Body for two purposes: participation in the FDA’s Voluntary Qualified Importer Program (VQIP) or to satisfy a request by the FDA that a food exported to the U.S. be accompanied by this certification (a request that may be made if the FDA suspects a food has the potential to be harmful to U.S. consumers). When a certification body conducts a regulatory audit, it must provide the FDA with a full report on the results of its inspection. The results of a consultative audit may remain private, but a certification body is required to report to the FDA if a consultative audit reveals issues that may pose a serious risk to consumer health.

Rule 5: Sanitary Transportation Rule

Compliance Dates:

  • Small Businesses (businesses other than motor carriers who are not also shippers and/or receivers employing fewer than 500 persons and motor carriers having less than $27.5 million in annual receipts): April 2018
  • All other businesses: April 2017

The Sanitary Transportation rule created new requirements for shippers, receivers, loaders, and carriers that transport food in the U.S. by motor or rail vehicle to ensure food is protected during transportation, via both the design and maintenance of transportation vehicles and equipment and by taking appropriate measures to ensure food safety by maintaining proper temperature controls and protecting food from contamination. Shippers, loaders, carriers, and receivers must develop written procedures detailing how they will ensure the safe transportation of food according to their specific requirements under the rule. The Sanitary Transportation rule applies whether or not the food is offered for or enters interstate commerce.

Rule 6: Intentional Adulteration Rule

Compliance Dates:

  • Very-small businesses (a business [including any subsidiaries and affiliates] averaging less than $10,000,000, adjusted for inflation, per year, during the three-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale [e.g., held for a fee].): May 2021
  • Small Businesses (a business employing fewer than 500 persons): May 2020
  • All other businesses: May 2019

As with the FDA’s Preventive Controls Rules, the Intentional Adulteration Rule applies to all facilities required to register with the FDA as a food facility, unless covered by an exemption (see section titled “Exemptions”). The rule requires facilities to develop and implement a written Food Defense Plan that assesses vulnerabilities within the facility, identifies a mitigation strategy for each vulnerability, and identifies monitoring procedures to ensure effectiveness of the mitigation strategies. A QI must prepare a facility’s Food Defense Plan.

Rule 7: Registration of Food Facilities

Compliance Dates:January 4, 2020.

Food facilities that manufacture and/or process, pack or hold food for consumption in the United States are required to register online with the FDA. This final rule adds new provisions to the current regulations to arrange certain provisions of FSMA. The registration include the requirement of an email address for registration, required renewal of registration every two years, and that all food facility registrations must contain an assurance that the FDA will be permitted to inspect the facility at the times and in the manner permitted by the Federal Food, Drug and Cosmetic Act.

In addition, the final rule adds certain new requirements that will improve the food facility registration system. All food facility registrations are required to be submitted to the FDA electronically, although this requirement does not take effect until January 4, 2020.

Registrations are now required to contain the type of activity conducted at the facility for each food product category. This will be required when the final rule becomes effective on July 14, 2016. The final rule also amends the definition of a retail food establishment in a way that expands the number of establishments that are considered retail food establishments, and that are therefore not required to register with the FDA as food facilities. However, all food establishments, including retail food establishments, continue to have a responsibility to ensure their food is safe.

Complying with FSMA

Registrar Corp’s FSMA Wizard is a free tool that helps you determine your possible requirements under FDA’s Food Safety Modernization Act (FSMA).

Registrar Corp’s Regulatory Specialists can assist with new requirements under FSMA, including developing or reviewing Food Safety Plans and Food Defense Plans. Registrar Corp’s FDA Compliance Monitor allows users to monitor their suppliers for FDA Import Alerts and Warning Letters, as required under FDA’s Preventive Controls Rules and FSVP Rule.

This article was originally published in Food Online.

Are you a food manufacturer and struggling to keep up with the growing demand of regulations, compliance and quality management? We can help automate processes and help food manufacturers become efficient and profitable. Contact us today to discuss: 949-253-9639