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12 Frequently Asked Questions on FSMA regulations

The Food Safety Modernization Act (FSMA) is a U.S. law enacted in 2011 aimed at improving food safety throughout the food supply chain. FSMA is a complex law with many new regulations. Therefore, it’s not surprising that many people have questions about how to implement these regulations. Here are 12 frequently asked questions about FSMA. These questions collected from GOL will help you better understand the provisions of FSMA and how to comply with them.

1. Frequently Asked Questions on FSMA regulations

1.1 Does a small-scale manufacturing facility need to establish FSMA procedures?

While there might be certain types of small-scale facilities not mandated to adhere to the entire FSMA procedure, implementing food safety measures is crucial to safeguard consumer health and maintain the business’s reputation. The applicability of FSMA regulations may vary depending on the business’s product category.

Frequently Asked Questions on FSMA regulations

1.2 Is the factory’s production scale a small business? Will the FDA be inspected?

For small businesses, the production scale is often smaller compared to larger companies, but the FDA may still conduct inspections to ensure that the manufacturing facility complies with necessary standards. Larger enterprises may undergo more frequent monitoring and have more extensive documentation to adhere to regulations.

1.3 If a business is subject to an FDA inspection, what should it prepare?

The manufacturing process documentation of the factory in English – updated according to FSMA standards to provide to the inspection.

  • The representative or interpreter communicates in English with the inspector.
  • Responding to FDA’s information request emails.

To better prepare the documentation and meet the inspection standards, businesses should contact GOL – consultants and service providers related to the FDA such as: FDA Food, Cosmetics, Medical equipment registration service who have been assisting businesses in preparing for FDA inspections since 2017 – for consultation and verification of their documentation and manufacturing processes to ensure they comply with FDA standards and address any issues before the FDA inspection.

Read more: Are FSVP food importers required to register with the FDA?

FDA inspection

1.4 Is FDA mandatory for commercial businesses to comply with FSMA/FSVP?

Yes, the FDA requires commercial businesses to comply with FSMA/FSVP to ensure the safety and quality of imported food products.

1.5 Which organization provides training and issues the FSMA certification for businesses?

Training on FSMA is typically provided by professional organizations and reputable training institutions in the field of food safety.

  • FDA (Food and Drug Administration): The FDA may organize training sessions and provide information related to FSMA.
  • FSPCA (Food Safety Preventive Controls Alliance): This non-profit organization was established to develop and deliver FSMA training. FSPCA often collaborates with training partners and issues certifications upon course completion.

1.6 When does FSMA 204 take effect?

The effective date for compliance is January 20, 2026. This signals the need to promptly initiate the development of a plan if your organization engages in the manufacturing, processing, packing, or storage of at least one food item listed on the Food Traceability List (FTL), which necessitates additional recordkeeping. This recognition has led to inquiries about the subsequent actions, particularly from our grocery and foodservice clients. The following are some of those inquiries, accompanied by links to resources that we trust will facilitate the progression ahead.

FSMA 204 - GOL

1.7 Why do I need to comply with FSMA? What happens if I don’t?

The primary objective of FSMA 204 is to facilitate prompt identification and removal of potentially contaminated food from the market, leading to a reduction in foodborne illnesses and fatalities.

Essentially, the regulation mandates companies involved in the manufacturing, processing, packing, or storage of foods on the FTL to maintain records containing Key Data Elements (KDEs) linked to specific Critical Tracking Events (CTEs). These companies must submit this information to the FDA within 24 hours or within an agreed-upon reasonable time.

It’s crucial to note that FSMA 204 is not a mere suggestion but a rule. Failure to comply voluntarily may result in various government actions, including civil or criminal proceedings in Federal court. Additionally, if the recordkeeping requirements are not met, an imported product may be denied admission to the U.S. marketplace.

1.8 Is a manufacturer of dietary supplements exempt from the “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” rule?

Dietary supplements fall under the category of “food” according to the Federal Food, Drug, and Cosmetic Act (FD&C Act). In general, both foreign and domestic facilities engaged in the production, processing, packaging, or storage of human food intended for consumption in the United States are required to register with the FDA under section 415 of the FD&C Act. They are also obligated to comply with the preventive controls outlined in the Current Good Manufacturing Practice, Hazard Analysis and Critical Control Point System, and Risk-Based Preventive Controls for Human Food rule unless they qualify for an exemption. Dietary supplements, however, are exempted from certain requirements under 21 CFR section 117.5(e). This exemption stipulates that subparts C (covering hazard analysis and preventive controls requirements) and G (related to supply-chain program requirements) of 21 CFR part 117 do not apply to facilities involved in the manufacturing, processing, packaging, or holding of dietary supplements, provided that these activities comply with the requirements outlined in 21 CFR part 111 (Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements) and section 761 of the FD&C Act (21 USC section 379aa-1) (Serious Adverse Event Reporting for Dietary Supplements).

Dietary supplements

1.9 My company operates three distinct food facilities. Is it necessary for us to develop three unique facility-specific food safety plans, even though we manufacture the exact same food product at all three locations?

Section 418 of the FD&C Act is structured around individual facilities. For instance, section 418(b) emphasizes that “[t]he owner, operator, or agent in charge of a facility must identify and evaluate known or reasonably foreseeable hazards that may be associated with the facility” (see the facility-based nature of the food safety plan in the 2013 proposed rule; 78 Fed. Reg. 3646 at 3732). Therefore, the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR part 117; 80 Fed. Reg. 55908) mandates that each facility must maintain its own written food safety plan. Even if a corporation produces similar products in separate facilities, it is improbable that these facilities have identical equipment and layouts. Procedural instructions must be customized to the specific equipment and layout of each facility, including processing lines, technologies, and raw materials used, as they influence the approach to implementing preventive controls such as allergen controls. 

1.10 What is the frequency of FDA updating the FTL?

FDA intends to revise the FTL approximately every five years. Stakeholders will have chances to provide input, such as submitting data for FDA to review concerning the Risk-Ranking Model used for the list. Upon the proposal of the updated list, there will be a public comment period. Deletions take immediate effect, while additions become effective two years after being announced in the Federal Register.

FDA updating the FTL

1.11 Are there advantages beyond mere compliance with FSMA 204?

While many companies acknowledge that FSMA 204 will incur additional costs and workload, particularly for already stretched and understaffed teams, there are notable benefits to implementing traceability by lot and date code. These include enhanced food freshness and a reduction in food waste.

Nevertheless, the primary advantage lies in creating a world where consumers trust that the food industry is taking every measure to protect them from contaminated food. This results in a world where the economy isn’t losing billions of dollars annually due to decreased productivity caused by illnesses among workers. In essence, the ultimate benefit is public health, and we all have a vested interest in that.

Moreover, it makes good business sense. Traceability data in the food industry offers valuable insights into your supply chain, empowering you and your business partners to make informed decisions about sourcing. This can lead to improved product quality, stronger supplier relationships, and increased returns on investment.

FSMA 204 rules

1.12 Am I exempt from all FSMA requirements if I am exporting to the US but exempt from the PSR (Produce Safety Rule)?

For exporters, especially those who are importers (such as a US-based owner or consignee of food offered for import into the United States or the US agency/representative of the foreign owner at the time of entry), compliance with the FSVP for Importers of Food for Humans and Animals is mandatory.

The FSVP rule necessitates that importers engage in specific risk-based activities to verify that food entering the United States has been produced in accordance with the relevant US safety standards.

FSVP equips the FDA with regulatory tools to supervise food safety and ensure that international producers of fresh produce adhere to the minimum regulatory compliance for food safety. This rule is the outcome of extensive collaboration between the FDA and various stakeholders, including industry representatives, consumer groups, regulatory counterparts at federal, state, local, and international levels, academia, and others. FSVP requirements are tailored to the risks associated with different types of foods, food hazards, and supplier performance. Importers have some flexibility in meeting these requirements.

Read more: Why is food safety important to the Food Business?

2. Learn more about complying with FSMA 204.

The Food Safety Modernization Act (FSMA) is a complex legislation with numerous new regulations. It’s crucial for businesses and individuals within the food supply chain to understand and adhere to these regulations. The article has addressed 12 frequently asked questions about FSMA regulations, providing essential insights. For more in-depth information and enthusiastic support, please visit GOL’s website. GOL is an FDA consulting company offering consulting, training, and technical support services to assist businesses in complying with FSMA. If you need expert guidance on FSMA compliance, feel free to reach out to us. Explore our resources to stay informed and ensure the safety and quality of your products.

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