STC Number - 203

Rule on materials derived from cattle and record-keeping requirements

Maintained by: United States of America
Raised by: Argentina; China
Supported by:
First date raised: October 2004 G/SPS/R/35, paras. 72-75
Dates subsequently raised:
Number of times subsequently raised: 0
Relevant documents: G/SPS/N/USA/933 and 934
Products covered: 33 Essential oils and resinoids; perfumery, cosmetic or toilet preparations; 0201 Meat of bovine animals, fresh or chilled.; 0202 Meat of bovine animals, frozen.
Primary subject keyword: Animal Health
Keywords: Animal health; Equivalence; Food safety; Human health; Transparency; Zoonoses
Status: Not reported
Date reported as resolved:

Extracts from SPS Committee meeting summary reports

Argentina noted that notifications G/SPS/N/USA/933 and 934 were published as regular notifications but were of immediate and compulsory implementation despite giving a timeframe for comments. Furthermore, Argentina was recognized as free of BSE but had to comply with the same requirements imposed on countries affected with BSE. The United States was requested to recognize the different disease status of Members as required in Article 6 of the SPS Agreement. China was concerned that the product description in the notification was too general and the HS tariff codes for the products covered by the two measures should be included. The notifications broadly included all trading partners exporting human food or cosmetics to the United States without taking into account the BSE status of different countries or regions. It was not necessary to restrict products from countries free of BSE nor should manufacturers be required to keep relevant records. These measures impeded international trade and the United States should provide scientific justification for its deviation from international standards and modify its measures accordingly.
The United States explained that notification G/SPS/N/USA/933 prohibited the use of materials derived from cattle in human food, including dietary supplements, and in cosmetics. Prohibited cattle materials included specified risk materials such as brain and spinal tissue, small intestine of all cattle, material from nonambulatory disabled cattle, material from cattle not inspected and passed for human consumption and mechanically separated beef. These restrictions were put in place to reduce the risk associated with BSE and the human disease variant Creutzfeldt-Jakob disease. The FDA issued an interim final rule effective immediately with a 90-day comment period ending on 12 October 2004 and would consider modifications on the final rule based on comments received. The requirements on prohibited cattle materials were imposed without exceptions to any products or ingredients of products manufactured in or imported into the United States. However, the United States recognized that a country's BSE status might merit consideration as the final rule was being developed. To this effect, the United States was seeking comments on the issue of equivalence as it related to BSE risk management requirements, as well as on standards to apply when determining another country's BSE status, providing an exemption for BSE free countries. The FDA and USDA were working to develop a harmonized US position on exempting other countries from respective requirements related to BSE which might be based, at least in part, on a country's BSE status as determined by the OIE.
Notification G/SPS/N/USA/934 was issued at the same time as G/SPS/N/USA/933 and required manufacturers and processors of human food and cosmetics that were manufactured from, processed with or otherwise contained material from cattle to establish and maintain records demonstrating that foods and cosmetics were in compliance with the interim final rule. The comment period of the proposed record-keeping rule ended on 13 August and the comments were currently being reviewed. The United States would notify the Committee of any changes incorporated in the final rule. The United States would include the HS codes as requested by China via a corrigendum to the two notifications.