This document is intended to provide information to foreign governments and other stakeholders on FDA’s proposed systems recognition assessment program, including the rationale for creating the program, implications of the program, how systems recognition assessments will be conducted, how information collected will be used, and what impact systems recognition may have on processes for importing foods. FDA intends to collect comments to inform its decision making process as FDA considers moving forward from a pilot phase to implementation. FDA previously used the term “comparability assessment” to describe the process of food safety systems evaluation as outlined in this document. FDA has since adopted the term “systems recognition assessment” as a more descriptive, plain-language term used to describe the same process.
The United States (U.S.) trades in food products with over 200 countries and territories and imports food products through over 300 U.S. ports. Imports of food to the U.S. have more than doubled in the past decade. This active international trade has allowed U.S. consumers to enjoy a wide variety of foods year-round, and U.S. consumers expect that all foods sold in U.S. markets will be safe for themselves and their families. Globally, there is substantial variation in the robustness of food safety systems, ranging from systems in the early stages of development to highly mature food safety systems. This variation heightens the challenge to FDA in developing effective import control systems. One of the opportunities in building a modern food safety system is in identifying countries with which FDA has strong knowledge, experience and confidence, where we may leverage resources to help ensure the safety of imported foods. FDA is faced with a challenge to design a system that enhances the safety of food imported into the United States and that operates in the most effective and efficient manner possible, while meeting our international obligations such as those under the World Trade Organization (WTO) Agreement on the Application of Sanitary and Phytosanitary Measures (SPS agreement)[i]. To meet this challenge, FDA is exploring ways to leverage the work of food safety authorities in countries that have food safety systems that are comparable to that of FDA. Applying the concept of systems recognition will allow FDA to leverage with appropriate food safety systems to improve food safety. FDA is developing a process to assess the capability of foreign food safety systems to help ensure the safety of foods produced under the oversight of the competent food safety authority/authorities. Systems recognition assessment provides a tool for identifying countries for the establishment of closer regulatory partnerships, including leveraging of work conducted by FDA and foreign food safety authorities.
A. A variety of approaches for working with other governments to ensure food safety.
An array of tools can be applied to imported food to help ensure its safety, including basic border control activities such as examination, sampling and analysis, facility registration, foreign inspections, and other verification activities, as well as the evaluation of exporting countries’ food safety systems or parts thereof.
It is important for FDA to match the appropriate tools to the capability of the exporting country’s food safety system and to recognize to what extent a country’s competent authorities may be capable and willing to contribute to assurances of food safety. Because the national food safety control systems in place in different countries are unique, have varying outcomes, and may differ in their approaches to providing assurances of the safety of foods exported to the United States, FDA may need to apply different tools to different countries or different commodities.
The FDA Food Safety Modernization Act (FSMA) provides FDA with a variety of new authorities to help ensure the safety of imported foods, and provides for taking into account the capability of the regulatory system of the exporting country to assure compliance with U.S. food safety standards for a given food[ii]. FSMA also directs FDA to consider bilateral and multilateral arrangements and agreements, including provisions, under specific situations, to provide for the responsibility of countries for the safety of food they export. To the extent possible, FDA will leverage the work done by foreign competent authorities to help ensure the safety of imported foods. For example, FDA may consider working directly with an export certification program of another country, develop bilateral commodity-specific arrangements, or develop protocols, agreements, or other arrangements regarding export certification programs. Systems recognition is simply one tool among many to acknowledge and take into account the role of the food safety system of an exporting country in risk-based decision making regarding inspections, monitoring, admissibility, and follow-up when food safety incidents occur. Systems recognition as a tool will be applied where FDA determines it can rely on food safety authorities’ implementation of science-based food safety regulatory programs and take regulatory action based on information provided by such regulatory authorities. This level of regulatory partnership and leveraging of work requires a rigorous assessment process to ensure that FDA is justified in recognizing foreign food safety systems and using the work of these foreign governments in FDA’s regulatory decision-making process.
B. Development of the Concept of Systems Recognition.
FDA recognizes that, to enhance the safety of imported foods and fulfill its public health mission in a global age, it must embrace new approaches that take into account the entire supply chain and its complexity. Consistent with FSMA and the recommendation of the President’s Food Safety Working Group[iii], FDA is focusing on preventing problems at appropriate points along the global food supply chain. Recognizing the potential value in leveraging the expertise of foreign food safety systems, FDA began exploring systems recognition assessments as a promising tool to assist in setting regulatory priorities, establishing closer regulatory partnerships, improving efficiency and strengthening our food safety system. The Imports Core Team of FDA’s “One Mission, One Program” initiative[iv] conducted the design and initial pilot activities for systems recognition assessments and further developed the concept under the FSMA implementation structure. In addition, FDA held a public hearing on March 30-31, 2011 to discuss the issue of systems recognition (at the time termed “comparability”) and to gather stakeholder input on its pilot systems recognition work[v].
FDA has been testing and developing a process for conducting systems recognition assessments, working with New Zealand and the European Union (EU) on initial pilot projects and Canada on a second pilot project, which are described in more detail in the Question and Answer section of this document. In 2010, with a Memorandum of Understanding (MOU) between the U.S. and New Zealand that covered seafood and non-Grade A dairy requiring updates, and based on consultation with New Zealand, FDA determined that including New Zealand in a pilot systems recognition assessment program would support the completion of the work needed to renew the MOU. In January 2011, FDA began work with the EU regarding an equivalence determination on molluscan shellfish, including a systems recognition assessment as one component of this work, which is ongoing.
C. FSMA - Providing Assurances for Imported Food.
FSMA provides FDA with an array of tools that can be applied to imported food to help ensure its safety. These tools account for the capacity of the regulatory systems in foreign countries to ensure their exports comply with U.S. food safety standards for designated foods. Additionally, section 305 of FSMA provides for FDA to consider how to build and leverage the food safety capacity of foreign governments, such as by negotiating bilateral and multilateral arrangements and agreements including provisions to provide for the responsibility of exporting countries for the safety of the food they export.
The “toolbox” that FDA has at its disposal to help ensure that imported food is safe includes:
- Border examinations, testing of samples, and compliance;
- Foreign inspections;
- Facility registration;
- The Foreign Supplier Verification Program (FSVP) under section 301 of FSMA;
- The Voluntary Qualified Importer Program (VQIP) under section 302 of FSMA;
- Requiring the utilization of accredited laboratories for testing;
- Reliance on the export programs of countries;
- Third party certification through, for example, the accreditation of third-party auditors under section 307 of FSMA;
- Requiring import certificates as provided under section 303 of FSMA;
- Bilateral agreements and arrangements; and
- Systems recognition or equivalence assessments of foreign food safety systems.
FDA expects that systems recognition assessments will be a key tool for FDA to utilize in its preventive approach to food safety for imported foods.
D. Pathway to Global Product Safety and Quality
In July 2011, FDA released a report that addresses the increasing globalization of FDA-regulated products, entitled “Pathway to Global Product Safety and Quality”[vi]. The report identifies several strategies to help ensure the safety of FDA-regulated products, including food, in a time of increasing globalization. These strategies include establishing closer regulatory relationships to build and strengthen the product safety net around the world, allocating Agency resources based on risk, and leveraging the combined efforts of government, industry, and public- and private-sector third parties.
FDA’s proposed systems recognition program provides an objective and transparent process for implementing the strategies outlined above, allowing FDA to foster close partnerships and leverage the work done by competent authorities in countries that have comparable food safety systems, and to focus FDA resources on areas of highest risk to help ensure a safe food supply for all U.S. consumers.
III. Questions and Answers
The following set of questions and answers provides information on systems recognition that may be of interest to foreign food safety authorities and other stakeholders, based on our experience, the New Zealand and EU pilot projects, input from the March 30-31, 2011, public hearing, and development of proposed regulations to implement FSMA, which are underway. We invite feedback on systems recognition, which may be submitted to SystemsRecognition@fda.hhs.gov.
A. FDA Processes under Development for Identifying Comparable Food Safety Systems
1. What is systems recognition?
For the purposes of this document, systems recognition describes whether: (1) a country’s food safety system provides a similar, though not necessarily identical, system of protections as another food safety system (in this case, the U.S. food safety system), and (2) the country’s food safety authority or authorities provide similar oversight and monitoring activities for food produced under its jurisdiction. Systems recognition is based on the conclusion that food safety systems with similar elements and similar levels of oversight lead to similar food safety outcomes.
FDA recognizes that food safety issues and outbreaks can arise in all countries, and systems recognition accounts for this reality. Systems recognition assessments, therefore, will focus not only on the ability of food safety systems to help ensure food safety, but also on the ability of food safety authorities to identify, address, and contain food safety issues and outbreaks that may arise, learn from past events, and strengthen the system over time.
2. How does FDA define "food safety systems" for systems recognition purposes?
For the purposes of this document, "food safety systems" refers to the governmental systems that cover the same scope as FDA’s system, including, where applicable, government oversight over third party food safety programs, to help ensure the safety of domestic and exported foods for human consumption.
3. What are the current steps in the process that FDA is developing to initiate and complete a systems recognition assessment?
FDA is developing a multiple-step process to be initiated after a country requests systems recognition. Generally speaking, when a country requests systems recognition, prior to initiating a full assessment, FDA will conduct an internal data review of the country’s compliance history including, for example, volume of trade, number of refusals of admission and reason(s) for refusal, products subject to import alerts, country reports (including information from the USDA’s Global Agricultural Information Network, and other available information). Upon completion of this review, FDA will arrange for a consultation meeting with the relevant food safety authority of the country (by teleconference or digital video conference). The participants at the consultation meeting will discuss FDA’s internal review, including any systemic concerns with the country’s food safety system, as well as the country’s goals and expectations in requesting the review. The participants will also discuss the steps involved in a systems recognition assessment and the expectations and requirements for a successful systems recognition determination.
Upon completion of the consultation meeting, countries may choose to pursue systems recognition, in which case the foreign food safety authority will complete the ICAT (once finalized).
After a country submits a completed ICAT, FDA will review the country’s submission in conjunction with the compliance history of products exported from the country. If these initial comprehensive reviews indicate that a country appears to have each of the elements in place and that they satisfy each of the ten ICAT standards FDA may arrange an in-country systems recognition assessment.
4. What does it mean for a foreign food safety system to be “comparable” to the U.S. food safety system?
A foreign food safety system is comparable to the U.S. food safety system if: (1) it provides a similar, though not necessarily identical, system of protections as the U.S. food safety system, and (2) the food safety authority or authorities provides similar oversight and monitoring activities for food produced under its jurisdiction.
FDA intends to conduct assessments of foreign food safety systems (under the oversight of foreign countries’ competent food safety authorities) through the application of ten standards, outlined in FDA’s draft International Comparability Assessment Tool (ICAT)[vii] systems recognition assessments on the review of these standards at the systems level as implemented by competent food safety authorities rather than on an assessment of a one-to-one correspondence of each country’s regulations or conducting firm-level compliance assessments. Each of the ten ICAT standards is comprised of elements that a country should have in place to satisfy the standard. The standards include: Regulatory Foundation; Training Program; Inspection Program; Program Assessment/Inspection Audit Program; Food-related Illness and Outbreaks; Compliance and Enforcement; Industry and Community Relations; Program Resources; International Communication and Harmonization; and Laboratory Support.
Because FDA recognizes the complexity of making meaningful comparisons between “food safety outcomes,” particularly with respect to outcomes as they relate to disease burden, FDA seeks comments from stakeholders on this topic. See questions 15 and 16 below for further discussion of the draft ICAT and FDA’s current thinking on how the elements that make up a food safety system correspond to food safety outcomes.
5. Could FDA deem a foreign food safety system to be comparable to FDA if that food safety system has more than one government authority sharing responsibility for ensuring the safety of foods?
Yes. Similar to the U.S. food safety system, a comparable food safety system in a foreign country could be comprised of one or more food safety authorities working in tandem to help ensure the overall safety of foods produced and processed in that country. However, FDA’s systems recognition assessment will be limited to those aspects of the food safety system pertaining to foods over which FDA has jurisdiction.
6. How does FDA plan to determine that a foreign food safety system is comparable?
FDA is developing a process for determining whether a foreign food safety system is comparable, through an assessment of the components of the foreign food safety system. To assist in this determination, FDA has developed a draft ICAT, as discussed in question 4 above. The draft ICAT is a self-assessment tool that, when finalized, will be completed by countries that request systems recognition. A thorough review by FDA of the completed ICAT, along with analyses of compliance information collected by FDA regarding products imported from that country (including volume of trade from the country under review and percentage of refusals), as well as results of in-country assessments of the foreign food safety system by FDA, will help FDA to determine whether the country has food safety systems that are comparable to those of the U.S.
Through this process, FDA provides a country that exports food to the U.S. the opportunity to demonstrate that its food safety system meets the elements listed in the ICAT.
7. What did FDA use as a model when drafting the ICAT?
To foster consistency with its domestic approach, FDA used the 2010 United States Manufactured Food Regulatory Program Standards (MFRPS) as a model in creating a draft of the ICAT.[viii] FDA developed the MFRPS to provide a uniform foundation for the design and management of U.S. State programs responsible for the regulatory oversight of food facilities. The draft ICAT, like the MFRPS, is comprised of ten standards and provides an objective framework for determining the robustness of trading partners’ overall food safety systems. The MFRPS provides a uniform basis for measuring and improving the performance of manufactured food regulatory programs in the United States. The draft ICAT, while based on the MFRPS, has been modified to apply to the oversight systems used by foreign food safety authorities from a broader scale, allowing for food safety systems that may differ from the U.S. system but offer the same level of public health protection.
8. Where can I obtain a copy of the MFRPS?
The 2010 MFRPS can be obtained from FDA’s web site at Manufactured Food Regulatory Program Standards.
9. Are animal feeds and pet food covered by the ICAT?
Not at this time. FDA used the 2010 MFRPS as a model in creating the draft ICAT. FDA developed the MFRPS standards for human food and FDA has not determined whether and to what extent the ICAT could be used to assess the production and processing of animal feed and pet food. Therefore, the draft ICAT cannot currently be used for identifying comparable animal feed safety systems. FDA is in the process of developing standards for animal feed regulatory programs, similar to the MFRPS, called the Animal Feed Regulatory Program Standards (AFRPS). The AFRPS will provide a uniform basis for measuring and improving the performance of animal feed regulatory programs in the United States. Once completed, the AFRPS may be used as a model for creating an international assessment tool to determine whether a country's feed safety system is comparable to FDA's system.
10. How is the draft ICAT structured?
The draft ICAT includes the ten standards outlined in Question 5: Regulatory Foundation; Training Program; Inspection Program; Program Assessment/Inspection Audit Program; Food-related Illness and Outbreaks; Compliance and Enforcement; Industry and Community Relations; Program Resources; International Communication and Harmonization; and Laboratory Support.
Each standard contains elements that describe certain components that should be in place to meet the requirements of that standard. To assist countries in completing the self-assessment, the draft ICAT includes U.S. references corresponding to each element, and describes the U.S. system with respect to each of the elements under each standard. Countries are offered the opportunity to explain in their ICAT submission how each element of their system may differ from that of the U.S. and how their system, though different, provides similar food safety outcomes with respect to each element.
11. The draft ICAT assessment involves a review of elements of a country’s food safety system. How will FDA relate the elements reviewed to actual food safety outcomes?
Analysis of the ICAT elements (once finalized) of a country’s food safety regulatory system, combined with in-country assessment including of the system’s inspection and compliance functions, and review of food safety outcome data from both the foreign and U.S. data sources should provide a comprehensive understanding of the foreign food safety system’s regulatory performance.
Through its regulatory experience, FDA believes that there is a close connection between the elements that comprise a food safety system and the measurable food safety outcomes associated with the food safety system. Food safety outcomes are typically evidenced by microbiological or chemical levels, incidence of food-borne disease, or some other quantitative food safety performance measure. FDA is currently considering additional correlations between food safety performance measures and the elements making up food safety systems as a way to measure a food safety system’s overall regulatory performance. Due to the breadth and scope of FDA-regulated products, defining these correlations across product areas is quite complex. FDA has discussed these issues with its regulatory partners, and has been engaged in ongoing discussions within the Codex Committee on Food Import and Export Inspection and Certification Systems (CCFICS) on monitoring regulatory performance of national food control systems. Once they are identified in the draft ICAT, FDA can assess those elements that support and define a country’s food safety system, including the laws, regulations, programs and policies that are in place to help ensure the safety of food. Based on FDA’s experience, FDA’s oversight of State programs, and the use of the MFRPS, from which the draft ICAT was developed, FDA believes that the elements reviewed through draft ICAT assessments correspond to likely food safety outcomes associated with the food safety system.
Following paper review of the country’s food safety system through the ICAT, FDA is able to perform in- country verification of the ICAT representations and to assess the country’s inspection and compliance programs, including shadow auditing inspectors in facilities that process different commodities and operate in different regions. These in-country assessments permit FDA to arrive at an objective and comprehensive preliminary means for assessing the competent food safety authority’s ability to help ensure that food produced in that country is safe.
Finally, systems recognition assessments will incorporate food safety outcome data from the food safety control systems of the country under review (e.g., review of the regulatory performance of the competent authority, verification records and hazard monitoring databases) as well as data collected by the U.S. (e.g., border examinations, notifications/recalls, FDA audits and inspections).
12. What is the purpose of the in-country systems recognition assessment and what will the assessment entail?
The first purpose of the in-country systems recognition assessment is to validate the information submitted by countries via the ICAT (once finalized) and reviewed by FDA. During the in-country systems recognition assessment, a team of FDA scientists, auditors, and investigators, including persons specializing in particular high-risk commodities, will visit government agencies and food processing facilities to conduct interviews and review records to verify the implementation of programs and measures as outlined in the ICAT response. Particular emphasis will be placed on observing the implementation of written policies, including oversight activities and enforcement of food safety regulations to ensure that the country’s program as implemented reflects a system that offers the same level of public health protection as the system implemented by FDA in the U.S.
The other purpose of the in-country systems recognition assessment is to review the country’s inspection and compliance programs and their ability to help ensure that food produced in that country is safe. This includes shadowing inspectors during inspections of facilities that process different commodities and operate in different regions.
13. How many inspections of food processing facilities should FDA observe during in-country systems recognition assessments?
FDA has not determined how many inspections of food processing facilities it will observe during in-country systems recognition assessments. FDA invites comments from stakeholders on developing factors to take into account to determine the appropriate number of on-site audits to conduct during in-country systems recognition assessments. Information from countries that have completed systems audits of other countries’ food safety systems and other stakeholders is requested.
14. How does FDA expect to determine whether a country’s food safety system continues to be comparable?
FDA expects to determine whether a country’s food safety system continues to be comparable through ongoing open bilateral communication and periodic review. FDA is developing a process whereby countries with comparable food safety systems will be expected to notify FDA when significant changes are made to their food safety systems. Likewise, FDA will notify countries that have systems recognition arrangements in place of any relevant changes to FDA’s system. Countries will also be expected to participate in an annual review meeting with FDA. At this meeting, countries will verify whether information previously submitted is up to date and accurate and will provide updates on any policy or programmatic changes under consideration. At predetermined intervals, FDA may conduct in-country reassessments to verify that food safety programs continue to be comparable.
In addition to scheduled reviews, if FDA or a comparable food safety authority acquires information of concern, unscheduled reviews may be initiated by either party. For example, if products from a country with a comparable food safety system were to be linked to an unusual food safety incident or emergency indicative of a widespread, systemic failure, either party may initiate an unplanned review.
15. Has FDA conducted any pilot systems recognition activities?
Yes. FDA initiated two pilot studies in 2010 as a means to extend existing arrangements with New Zealand and establish new arrangements with the EU.
FDA and food safety agencies in New Zealand have several cooperative arrangements with each other relating to food safety. To facilitate the renewal of existing arrangements between the United States and New Zealand, the New Zealand Ministry for Primary Industries (at the time called the New Zealand Food Safety Authority) agreed to participate in a pilot systems recognition assessment using an early draft version of the ICAT.
In addition, FDA is exploring the use of systems recognition assessments to provide FDA with an objective basis for establishing and documenting its knowledge, experience, and confidence in the food safety systems of other governments to support equivalence determinations. During bilateral discussions with the European Commission in early 2010, FDA considered the role of the Codex Guidelines on the Judgment of Equivalence of Sanitary Measures Associated with Food Inspection and Certification systems (CAC/GL 53/2003)[ix] in making equivalence determinations of each other’s food safety controls for shellfish. FDA determined that systems recognition assessments would provide FDA with an objective basis for applying the Codex concept of relying on FDA’s knowledge, experience, and confidence in the EU system to support this equivalence determination. Currently, FDA and the European Commission are in the process of conducting equivalence assessments of each other's systems for shellfish.
A third pilot is also underway to assess the food safety system of Canada, under the U.S. – Canada Regulatory Cooperation Council (RCC).
16. Does FDA view systems recognition the same as equivalence?
No. FDA does not view systems recognition the same as equivalence. The term "equivalence" is used principally in the context of the international trading regime established under the WTO and its associated agreements, including the SPS Agreement, and in other free trade agreements, such as the North American Free Trade Agreement.
To date, FDA has considered equivalence as most appropriately applied to the assessment of a foreign government’s specific programs for certain high risk foods. This type of assessment provides a very detailed comparison of each measure that a country applies in controlling risks associated with the particular commodity under review. While this approach may be appropriate for assessing particular measures in specific commodity areas, FDA believes that the measure-by-measure approach is not required for the assessment of a system-wide level of protection, and that the proposed systems recognition approach is more appropriate in this context.
FDA will apply systems recognition to the assessment of a country’s overall food safety system (both domestic and export), to determine whether the system as a whole offers a similar, though not identical, system of protections as does the FDA food safety system.
17. Will FDA expect a systems recognition determination to be used in combination with an equivalence assessment?
Yes, at times. A systems recognition determination can help facilitate an equivalence assessment with respect to a specific commodity but is not a prerequisite for an equivalence determination. There are many components of a food safety system and many measures that could be assessed in the equivalence process. A systems recognition determination considers the similarity of a food safety system to that of the U.S. by, in part, identifying and acknowledging system features that are analogous to those in the U.S. Once a systems recognition assessment has provided FDA with an objective measure of FDA’s knowledge, experience, and confidence relating to the country’s overall food safety system, the equivalence assessment can then focus on those specific measures, practices, or activities associated with a particular high risk food where there are technical or scientific questions about particular measures or groups of measures.
For example, in conducting equivalence activities related to bivalve molluscan shellfish under the U.S.-EU Veterinary Equivalence Agreement (VEA), FDA has been working with European Commission officials on shellfish-specific issues such as shellfish growing water classification and shellfish testing policies and protocols. FDA and European Commission officials see these issues as critical to helping ensure the safety for consumers of bivalve molluscan shellfish and are thus assessed during equivalence determinations in great detail. By contrast, systems recognition assessments would not routinely focus on discrete sets of regulatory measures and food safety standards associated with specific high risk foods. Rather, systems recognition assessments focus on the laws and regulatory programs that countries have in place, and their implementation. A systems recognition assessment may provide the foundation for an equivalence determination, where appropriate, by providing an objective assessment of FDA’s knowledge, experience, and confidence in a country’s overall food safety system.
18. Are there aspects of food safety systems that will not be covered during systems recognition assessments?
Yes. FDA will not include certain product specific regulatory requirements and food safety standards, such as labeling requirements and maximum residue levels for pesticide and veterinary drug residues in foods, in systems recognition assessments. Countries may have food safety systems that are comparable to that of the U.S. yet include specific requirements and food safety standards that differ from those of the U.S. In these cases, exporters and importers of food to and from the U.S. must ensure that the requirements of importing countries are met as a matter of compliance.
19. Systems recognition assessments include a complete assessment of a country’s entire food safety system. Is FDA considering options for assessing commodity-specific export systems?
Yes. FDA welcomes comments on ways that we might leverage work done by countries on a commodity-specific basis.
B. Possible Uses of Systems Recognition Determinations by FDA
20. Once FDA has determined that a country has a comparable food safety system, how does FDA plan to use this information?
FDA’s inspection and surveillance activities are prioritized based on risk. Information gathered through a food safety system assessment will be useful in informing this prioritization process. FDA also proposes to use systems recognition determinations as one factor in prioritizing resources dedicated to foreign facility inspections, import field exams, and import sampling.
While inspection and testing of foods will continue to inform FDA’s risk-based food safety program, FDA’s shift to a preventive approach, which will include systems recognition as one of several tools, will hold those that produce, process, and import foods responsible and accountable for ensuring the safety of their products.
Beyond inspection and surveillance activities, systems recognition has the potential to offer FDA an objective basis for relying on information provided by comparable foreign authorities and avoiding the duplication of work conducted in countries with comparable food safety systems. FDA anticipates that systems recognition will offer FDA an opportunity to foster stronger ties with food safety authorities in other countries, and to enhance data sharing and information exchange to support food safety efforts. Systems recognition arrangements could complement new or existing Confidentiality Commitments whereby comparable food safety authorities will be able to exchange non-public information with FDA related to food safety to address food safety issues in a timely and proactive manner, improving the safety of foods for consumers in each country.
FDA invites comments on other ways that FDA may use the results of systems recognition assessments in such areas as building regulatory partnerships, information exchange, and collaboration.
21. Will countries that are not deemed comparable or that do not seek systems recognition be able to export food to the U.S?
Yes. A determination by FDA that a country’s food safety system is comparable is not required for food from that country to be imported into the U.S. In all cases, imported food must comply with applicable U.S. requirements.
22. Will systems recognition determinations be reciprocal?
Ideally, but not necessarily. Recognizing that food safety authorities in other countries may have different statutory requirements, the issue of reciprocity likely will be addressed on a case-by-case basis. FDA invites comment from food safety authorities and other stakeholders on the feasibility of reciprocal systems recognition assessments and determinations.
23. What are the next steps for implementing systems recognition activities?
FDA has completed its pilot with New Zealand and is currently completing pilots with the EU and Canada, as described previously in this document. After completion of these pilots, FDA will revise and/or update the systems recognition assessment process as appropriate. Once revisions to the proposed process are complete, FDA will consider whether to implement the program on a full scale.
24. Has GAO published a study related to systems recognition?
Yes. GAO published a study in 2012 called "FDA Can Better Oversee Food Imports by Assessing and Leveraging Other Countries’ Oversight Resources."[x]. In this report GAO advised that FDA consider expanding the use of systems recognition to include commodity-specific export programs. In its response, FDA indicated that systems recognition is considered to be a more efficient and appropriate tool for FDA to use in assessing whether a country’s entire food safety system provides adequate assurances of comparable public health outcomes, while third party certification is a more appropriate approach for FDA to use when assessing a particular segment of the food safety system—e.g., export controls for one or more commodities. As described in FDA comments published with the GAO report, FDA is developing the Systems Recognition and Accredited Third Party Programs as complementary tools that FDA may use to assess countries’ food safety systems, or parts thereof, specific to countries’ particular capabilities, interests and maturity of their regulatory system. Food safety authorities in other countries may wish FDA to assess their food safety systems as a whole through systems recognition or they may pursue assessments of their food safety controls and oversight for particular export products through the third party accreditation program. The selection of the most appropriate tool for a particular country will be made jointly by FDA in consultation with the food safety authority of that country.
25. Has FDA conducted any outreach activities related to systems recognition?
Yes. On March 30-31, 2011, FDA conducted a 2-day public hearing entitled "Ensuring the Safety of Imported Foods and Animal Feed: Comparability of Food Safety Systems and Import Practices of Foreign Countries." During this hearing, FDA presented information on a pilot project with New Zealand that was underway to assess foreign food safety systems to identify systems that offer a comparable level of public health protection as the U.S. food safety system for FDA regulated foods. The hearing offered an opportunity to obtain information from stakeholders and to provide stakeholders the opportunity to learn about FDA's food safety initiatives, including the use of systems recognition assessments as one of several mechanisms to enhance the safety of foods imported to the United States. FDA encouraged stakeholders to provide feedback on pilot systems recognition projects and equivalence determinations through the hearing docket.
The public hearing included presentations from officials from U.S. government agencies (FDA, Office of the U.S. Trade Representative, the United States Department of Agriculture’s Food Safety Inspection Service (USDA, FSIS) and the U.S. Codex Office). Officials from Australia, Canada, the European Commission, Mexico, and New Zealand presented their perspectives on assuring the safety of imported foods as well as their perspectives on the use of systems recognition assessment as one tool in determining the safety of imported food. Representatives of a consumer organization, an agricultural development organization, the food industry, several governments, and individual citizens provided testimony at the public hearing. View the agenda and transcript of the public hearing.
As of May 15, 2013, FDA had verified the Web site address for the listed below, but FDA is not responsible for any subsequent changes to Non-FDA Web site references.
 In developing this process, FDA consulted with colleagues from the USDA’s Food Safety Inspection Service regarding its processes and procedures for initiating equivalence determinations for meat and poultry. FSIS indicated that equivalence determinations proceed only in cases where the country seeking review, having reviewed the FSIS equivalence self-assessment tool, determines that they are indeed likely candidates and have the resources necessary to complete the review. Through discussions with FSIS, FDA believes that countries seeking systems recognition will likewise self-select based on the level of development of their food safety system and their commitment and ability to complete the review process.
 At that time termed “comparability.”
 When FDA first began its pilot activity with New Zealand in 2010, FDA used the term “comparability assessment” to describe the process of food safety systems evaluation. FDA has since adopted the term “systems recognition assessment” as explained in the Introduction section of this document.
[iii] President’s Food Safety Working Group’s Key Findings.
[iv] The Imports Core Team of FDA’s “One Mission, One Program” Initiative.
[v] Comparability Public Hearing (Docket No. FDA-2011-N-0135).
[vi] Pathway to Global Product Safety and Quality.