STC Number - 375

US non-acceptance of OIE categorization for BSE

Maintained by: United States of America
Raised by: India
Supported by:
First date raised: July 2014 G/SPS/R/75paras. 4.9-4.10
Dates subsequently raised: October 2014 (G/SPS/R/76 paras. 3.22-3.23)
March 2015 (G/SPS/R/78 paras. 3.26-3.29)
July 2015 (G/SPS/R/79 paras. 3.31-3.34)
October 2015 (G/SPS/R/81 paras. 3.63-3.64)
March 2016 (G/SPS/R/82 paras. 3.46-3.47)
Number of times subsequently raised: 5
Relevant documents: Raised orally
Products covered: 01 Live animals; 02 Meat and edible meat offal
Primary subject keyword: Animal Health
Keywords: Animal health; International Standards / Harmonization; Risk assessment; Bovine Spongiform Encephalopathy (BSE)
Status: Not reported
Solution:
Date reported as resolved:

Extracts from SPS Committee meeting summary reports

In July 2014, India raised its concern regarding the US request for India's OIE dossier, which it had previously submitted to the OIE in order to gain recognition of its status as a negligible risk country for BSE. India noted that the United States had chosen to disregard the OIE's designation, which was contrary to accepted international practice among Members, and had instead requested India to share its OIE dossier in order to enable the United States to conduct their own assessment of India's status. Given the significant trade interest, India had requested the OIE to share its dossier with the United States, but further requested that the United States recognize its official OIE status.

The United States reiterated its commitment to aligning its import regulations governing BSE with OIE guidelines and further highlighted that in 2013, USDA APHIS had published a final rule in the Federal Register that ensured that US BSE import regulations were aligned with international animal health standards that support safe trade in bovines and bovine products. In that rule, it had been noted that the review of information for India was ongoing. If the findings supported concurrence with OIE's designation, a notice would be published in the Federal Register. However, the United States indicated that it had been unable to complete its review due to the lack of access to India's OIE dossier, in spite of repeated requests since 2010. Although India had authorized the OIE to share a copy of the dossier in May 2014, this information had still not been received. The United States reiterated its request for India to provide the necessary information to facilitate the evaluation and indicated its willingness to continue working with India on the issue.

In October 2014, India restated its concern that the United States did not accept the OIE categorization of India as a negligible risk country for BSE. India recalled that OIE defined the standards for six diseases including BSE, and that India followed these standards in line with the SPS Agreement. India reminded Members to apply OIE designations instead of conducting their own national assessments, and noted that the United States had chosen to disregard the OIE designation, which was contrary to accepted international practice among Members. India requested the United States to recognize its official OIE BSE status.

The United States reiterated its commitment to aligning its import regulations governing BSE with OIE guidelines. The United States had received India's OIE dossier on 18 September 2014, and was currently reviewing India's status, with an opportunity for public comments.

In March 2015, India restated its concern that the United States did not accept the OIE categorization of India as a negligible risk country for BSE. India recalled that the OIE defined the standards for six diseases including BSE, and that India followed these standards in line with the SPS Agreement. India reminded Members to apply OIE designations instead of conducting their own national assessments, and noted that the United States had chosen to disregard the OIE designation, which was contrary to accepted international practice among Members. India requested the United States to recognize its official OIE BSE status.

India also reiterated its concern regarding Australia's non-acceptance of its OIE categorization as negligible risk country for BSE. India noted that Australia had chosen to implement its own categorization process and voiced concerns about the multiplicity of systems, as well as the risk that national categorization processes would contradict the OIE's categorization. India requested that Australia share the reasoning behind its diverging view in determining a negligible risk country.

The United States reiterated its commitment to aligning its import regulations governing BSE with OIE guidelines. The United States had received India's OIE dossier on 10 September 2014, and was currently reviewing India's status, with an opportunity for public comments.

Australia indicated that, consistent with the SPS Agreement, it reserved its right to conduct its own risk assessments on the status of India or any other Member in relation to diseases of biosecurity concern, including BSE, in accordance with its appropriate level of protection.

In July 2015, India restated its concern that the United States and Australia did not accept the OIE categorization of India as a negligible risk country for BSE. India had shared its OIE dossier with the United States, but had not received any response yet. India urged both countries to carry their assessment in accordance to OIE standards.

The United States restated its commitment to align its import regulations governing BSE with that of OIE guidelines as reflected in USDA APHIS final rule published in 2013. It was currently reviewing India's OIE dossier, and the result would be published and public comments welcomed.

Australia said it hoped previous bilateral discussions with India had helped to clarify Australia's position and reiterated that it reserved its right to conduct its own risk assessments on India's or any other Member's status in relation to diseases of biosecurity concern, including BSE, in accordance with its appropriate level of protection.

India referred to the explicit recognition of OIE standards under Annex A.3 of the SPS Agreement, and invited the United States and Australia to share any additional factors that would be taken into consideration in determining India's BSE status.

In October 2015, India restated its concern that the United States did not accept the OIE categorization of India as a negligible risk country for BSE. India had shared its OIE dossier with the United States, but had not received any response yet. India urged the United States to carry out the assessment in accordance with OIE standards.

The United States reiterated its commitment to align its import regulations governing BSE with that of OIE guidelines as reflected in USDA APHIS final rule published in 2013. It was currently reviewing India's OIE dossier, and the result would be published and public comments welcomed.

In March 2016, India reiterated its concerns with the US non acceptance of the OIE categorization of India as a "negligible risk country" for BSE. India recalled that it was considered as a negligible risk country by the OIE, based on the dossier it had submitted. India reported that the United States refused to accept this categorization, prompting India to send the dossier to the United States to carry out an independent assessment. India was concerned that this led to double certification requirements - one specific to the United States and the other for other Members. India requested that the United States accept the OIE categorization and act upon the submitted dossier so that a standard certificate could be issued for by the Indian authorities for all Members.

The United States expressed its full commitment to align its import regulations, governing BSE with OIE guidelines. The United States reported that in 2013, USDA's Animal and Plant Health Inspection Service (APHIS) had published a final rule in the Federal Register which ensures that US BSE import regulations are in line with international animal health standards that support safe trade in bovines and bovine products. On 4 December 2015, USDA APHIS had published a Notice in the Federal Register advising the public of preliminary concurrence with the OIE's BSE negligible risk designations for 16 regions, including India. The United States stated that other countries covered by this notice were Bulgaria, Cyprus, Czech Republic, Estonia, France, Hungary, the Republic of Korea, Latvia, Liechtenstein, Luxembourg, Malta, Portugal, Romania, Slovak Republic, and Switzerland. The United States indicated that the comment period for the Notice had closed on 4 February 2016, and the next step would be publication of the second Notice finalizing US recognition of these 16 regions, including India, as negligible risk for BSE.