STC Number - 299

US 2009 Food Safety Enhancement Act

Maintained by: United States of America
Raised by: China; India
Supported by: Costa Rica; Jamaica; Mexico; Pakistan; Philippines
First date raised: June 2010 G/SPS/R/59 paras. 21-23
Dates subsequently raised: March 2011 (G/SPS/R/62 paras. 43-47)
June 2011 (G/SPS/R/63 paras. 42-45)
October 2011 (G/SPS/R/64 paras. 52-54)
March 2012 (G/SPS/R/66 paras. 61-63)
Number of times subsequently raised: 4
Relevant documents: G/SPS/N/USA/690/Add.11 G/SPS/N/USA/704/Add.2 G/SPS/N/USA/2156 G/SPS/N/USA/2156/Add.1 G/SPS/N/USA/2156/Add.2 G/SPS/N/USA/2156/Add.2/Rev.1 G/SPS/N/USA/2156/Add.3 G/SPS/N/USA/2156/Add.3/Rev.1 G/SPS/N/USA/2156/Add.3/Rev.1/Corr.1 G/SPS/N/USA/2156/Add.4 G/SPS/N/USA/703/Add.3 G/TBT/W/349
Products covered:
Primary subject keyword: Food safety
Keywords: Control, Inspection and Approval Procedures; Food safety; Human health; Equivalence; Transparency; International Standards / Harmonization
Status: Not reported
Date reported as resolved:

Extracts from SPS Committee meeting summary reports

In June 2010, China expressed concerns related to the US 2009 Food Safety Enhancement Act. The US Congress had proposed several new measures, including required registration for export food companies, follow-up inspections, compulsory certification for high risk imported products and the expansion of FDA authority. China asked the United States to notify these new measures and to provide the opportunity for Members to make comments before the adoption of the legislation.

India expressed the need to understand the proposed legislation. Indian industry had questions regarding the duration of the registration process, whether it was modelled on international standards, whether foreign government and sector associations would be notified before or after a food facility was inspected, and how the fast-track process for registration would work. Once it had a better understanding of this process, India would seek further clarification.

The United States clarified that the US Congress was in the process of considering this legislation and it was not clear when the bill would become law, if at all. Accordingly, because the Food Safety Enhancement Act was not a SPS measure, the United States did not believe it was appropriate to comment on it at this time. However, if this bill or any other food safety legislation did become law, the United States would alert its trading partners, and would notify the WTO accordingly.

In March 2011, China, supported by Costa Rica and Pakistan, stated that despite promises to that effect, the United States had not notified the draft US Food Safety Modernization Act (FSMA) before the Act was formally adopted in January 2011. Hence, Members were only provided an opportunity to comment on the Act when it was notified by the United States on 2 March 2011. China asked that the United States notify draft regulations from the Act so that Members would have an opportunity to provide comments.

Jamaica raised several concerns regarding the FSMA relating to: (i) guidelines on the mandatory preventative controls for food facilities; (ii) produce safety standards in place in Jamaica and other CARICOM countries; (iii) the status of the Jamaican Bureau of Standards' inspection checklist vis-à-vis the mandatory inspection of foreign facilities commencing in 2012; (iv) special and differential treatment with regards to the implementation period for enhancing food tracing and record-keeping; (v) foods tested by an accredited laboratory in Jamaica and whether they would need to be tested in the United States; (vi) the determination of the eligibility of a body listed as one of the accreditation bodies; and (vii) training and funding on the interpretation and implementation of the Act.

The Philippines requested that the measures and standards of the Act not be unnecessarily burdensome nor unduly increase the cost of compliance for small industries. Mexico expressed concern regarding the administration of foods and that some elements of the Act were not based on science. Mexico noted that it would submit its comments to the relevant authorities.

The United States indicated that Members would be given an opportunity to comment on draft regulations before they were finalized and became binding on affected parties, including food manufacturers and importers. The FSMA required that FDA publish regulations and guidance documents to implement the provisions of the law and the FDA would publish those documents over the next several years. Regarding Jamaica's comments on food controls, regulations would be developed and Jamaica would have the opportunity to comment during the drafting process. The concerns regarding the inspection frequency and checklists, would be forwarded to the FDA for consideration. The United States further noted that concerning Jamaica`s queries on food tracing, record-keeping and laboratory accreditation, draft regulations would take into consideration information provided by Members as well as existing arrangements. Finally, it was noted that the FDA was still developing plans with regards to capacity development.

In June 2011, India indicated that the FSMA introduced an elaborate multi-layered scheme of checks within the food supply chain to minimize the possibility of food contamination, putting extra burden on exporters and leading to higher transaction costs. In this light, India sought clarification on several key issues, including the foreign supplier verification programme, the voluntary qualified importer programme, certification and audit, and regulations to be introduced under the FSMA. India urged the United States to ensure the FSMA was in line with the SPS Agreement and the Codex principles and guidelines for the design, operation, assessment and accreditation of food import and export inspection and certification systems.

China expressed disappointment that the United States did not notify nor provide a sufficient comment period. To avoid unnecessary restrictions on trade, the United States should consider the compatibility of the FSMA regulations with those of developing country Members with whom the United States had signed bilateral SPS protocols. Bearing in mind the importance of food and agricultural exports for developing country Members, the United States should provide a sufficient transition period, as well as technical assistance, for developing country Members to adapt to the new requirements.

Mexico remained concerned about the administrative procedures in Section 207, the requirements for accreditation, the inspection procedures regarding control and approval in Section 306, the possibility of recognition of equivalence between countries or Memoranda of Understanding, and Section 301 regarding foreign suppliers. Mexico appreciated the US presentation at the last Committee meeting and the meetings between Mexican and FDA authorities in June.

The United States emphasized its commitment to implementing FSMA in a transparent manner according to its WTO obligations, and keeping in mind Codex standards, guidelines, and texts. It had notified FSMA as G/SPS/N/USA/2156 in February 2011, and the FDA had conducted numerous outreach sessions including a special session at the March SPS Committee meeting to provide detailed explanations of the law. The United States had received comments from China and Mexico, but not from India, before the June meeting. The FDA had not yet implemented the provisions regarding foreign supplier and voluntary importer programmes and welcomed Members' comments when these provisions were notified, in particular scientific evidence on potential health and safety concerns and data on economic impacts. The United States reported that it would notify all implementing regulations to foreign stakeholders through the WTO, as they were developed and consistent with its international obligations. A series of events had been organized between FDA representatives in Delhi and relevant Indian authorities, including a briefing on the FSMA in February 2011, a discussion regarding third party certification in May 2011, a series of four-day workshops to over 175 participants in May 2011, and a meeting with senior Indian officials and exporters in October 2011.

In October 2011, China emphasized the importance of food and agricultural exports for developing country Members, and urged the United States to provide a sufficient transition period before implementation of the FSMA, as well as technical assistance for Members to adapt to the new requirements.

India stated that the FSMA created extra burdens for exporters and led to higher transaction costs. India argued that various provisions of the FSMA did not reflect the core principles of equivalence (Article 4) and harmonization (Article 3) of the SPS Agreement, and urged the United States to ensure the FSMA was in line with the SPS Agreement so as not to affect trade between Members. India's key concerns related to the registration of Foreign Food Facilities, the Voluntary Qualified Importer Program, Certification and Audit and the Foreign Supplier Verification Program.

The United States noted that FDA was as transparent as possible, including making presentations to the SPS Committee, holding numerous outreach sessions with all stakeholders, keeping current information on the Web. The United States was committed to implement FSMA in a transparent manner consistent with its WTO obligations and would take into account relevant Codex standards and guidelines. The FDA had issued interim final rules requiring persons submitting prior notice of imported food to report any other countries' refusal of the food (G/SPS/N/USA/690/Add.11) and had also amended criteria used to order administrative detention of food for human or animal consumption (G/SPS/N/USA/704/Add.2). The FDA had not yet issued regulations for the FSMA provisions for the foreign supplier and voluntary importer programmes. Members could comment when the proposed rules were notified. The United States welcomed Members' perspectives on implementation of the FSMA.

In March 2012, India recalled that in October 2011 it had raised concerns that the FSMA put extra burden on exporters, and reiterated the provisions of greatest concern. India urged the United States to communicate the timeframe for the issuance of these regulations, and asked whether the regulations would provide for bilateral mutual recognition agreements that could help Indian exporters access the US market. India also requested information on how much time would be provided to exporters to meet new requirements, as this would require technical assistance and better understanding to ensure all regulations were fully followed. India also requested clarification about the additional costs to exporters for the registration of foreign suppliers.

China echoed the concerns of India, and recalled the US document G/TBT/W/349 concerning the use of the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) and the International Accreditation Forum (IAF) Multilateral Recognition Arrangement (MLA) by central government bodies. China requested confirmation that the US FDA had taken concrete steps to accept test results issued by testing laboratories from exporting Members accredited under the ILAC MRA framework.

The United States recalled that it notified FSMA and certain user fee rates in February and October 2011, respectively (G/SPS/N/USA/2156 and addenda). An interim final rule had been notified (G/SPS/N/USA/703/Add.3) to amend FDA's regulation on the record availability requirements. The amendment expands FDA's access authority to records relating to any other article of food that the Secretary of Health Human Services reasonably believes is likely to be affected in a similar manner. Trading partners should submit comments on the notified measures. The United States hoped to soon publish proposed rules relating to preventive controls for human foods and animal feed, produce safety, foreign supplier verification, and third-party accreditation. The FDA would be mindful of the Codex Alimentarius standards, guidelines and related texts, while ensuring FSMA programmes provided the appropriate level of health protection for US consumers.