For traders looking to import food into the U.S. market, the FSVP representative is one of the important requirements. So, what is FSVP? Who is required to adhere to its regulations? In this article, UCC will clarify the information related to FSVP that business owners need to know.
1. What is an FSVP Representative?
According to the Food Safety Modernization Act of 2011 (FSMA), certain importers in the United States are required to establish a Foreign Supplier Verification Program (FSVP) to ensure that foreign suppliers producing food comply with safety procedures. Specifically, this requirement aims to enhance food safety standards and protect public health. Moreover, by implementing the FSVP, importers can better assess and manage risks associated with imported food products. This ensures that these processes provide a level of public health protection comparable to the requirements outlined in sections 418 (Hazard Analysis and Risk-Based Preventive Controls, or “HARPC”) or 419 (Standards for the Safety of Produce) of the Federal Food, Drug, and Cosmetic Act.
1.1. Scope of FSVP Representative
The FSVP program primarily targets businesses importing food into the United States. Additionally, as defined by the FDA, an FSVP representative is typically the entity responsible for importation. Thus, the FSVP representative can be:
- The owner or recipient of the food intended for import in the U.S.
- The U.S. representative or agent acting on behalf of the foreign owner at the time of entry.
1.2. FSVP Representative Rules
The rules require that the FSVP representative carry out verification activities based on risks to demonstrate that:
- The food is produced following proper procedures that ensure a level of public health protection akin to those in sections 418 or 419, if applicable.
- The food is free from contamination as stated in section 402 of the FD&C Act.
- The food intended for human consumption is accurately labeled as per section 403(w) of the FD&C Act, particularly concerning allergen labeling.
2. Why is an FSVP Representative Necessary?
It is evident that the FSVP is designed to enhance the safety of food consumed in the United States. Consequently, it primarily affects importers, who must verify that any food they import meets all mandatory U.S. safety standards. Specific objectives of the FSVP include:
- Control and Risk Assessment:
The FSVP mandates that importers undergo a process to identify and evaluate risks associated with food safety from foreign suppliers. This, in turn, encompasses not only assessing production but also evaluating storage, transportation, and other aspects of the supply chain.
- Maintaining Detailed Records:
Importers must establish and maintain comprehensive records regarding their foreign suppliers. Specifically, these records should include information on production processes, quality controls, and other risk management measures. Furthermore, maintaining such detailed documentation is essential for ensuring compliance and enhancing food safety.
- Establishing Risk Control Measures:
Based on risk assessments, importers are required to implement measures to mitigate or eliminate food safety risks. In particular, this may involve establishing controls at international checkpoints or U.S. entry ports. Additionally, these measures are crucial for ensuring compliance with safety regulations and protecting public health.
- Adherence to FDA Regulations:
The FSVP ensures that imported food meets FDA food safety standards, including controls on additives, pesticides, and other factors affecting food safety.
3. Duties of an FSVP Agent
- Verify Food Safety Compliance:
The FSVP representative is responsible for confirming that foreign suppliers produce food according to U.S. safety standards. This includes, for instance, regulations on sanitation, contamination control, and production safety. Furthermore, the representative plays a vital role in ensuring ongoing compliance with these standards.
- Assess Risks of Foreign Suppliers:
They must evaluate risk factors related to foreign suppliers, including their compliance history, food types, and safety controls in place.
- Engage in Verification Activities:
Verification may include, for example, reviewing documentation, monitoring production processes, and conducting regular inspections of imported food to ensure compliance with safety standards. Additionally, these steps help to maintain high safety levels throughout the supply chain.
- Report and Collaborate with the FDA:
In case of food safety issues, the FSVP representative must collaborate with the FDA, providing information and records as required and assisting in investigations or product recalls if necessary.
- Conduct Ongoing Reviews and Evaluations:
They must periodically assess the effectiveness of the FSVP to ensure that foreign suppliers continue to meet food safety requirements.
4. About UCC
UCC offers registration and consulting services to help businesses understand and comply with FDA legal requirements. This includes addressing issues related to labeling, ingredients, and updated food safety standards.
- Authorized Representation in the U.S.:
If a business lacks an office or representative in the U.S., UCC can provide FSVP representative services to ensure compliance with FDA requirements.
- UCC’s Evaluation of Foreign Suppliers:
UCC assists in evaluating and verifying that foreign suppliers meet necessary food safety standards, including inspecting production processes and hygiene management.
- Maintaining and Managing FSVP Records:
UCC ensures that it adequately stores all FSVP-related documents, including verification, assessment, and risk control records, making them ready for FDA inspections.
- Support During FDA Inspections and Issues:
In the event of an FDA inspection or request, UCC supports businesses in providing information and liaising with the FDA to resolve any food safety issues.
We hope this article has provided you with a clearer understanding of FSVP and its related requirements. Additionally, we encourage you to carefully consider your choice of partner when registering with the FDA. UCC is confident in being a reliable partner in providing solutions related to FDA and FSVP. If you have any questions, please do not hesitate to contact UCC for prompt assistance.
