STC Number - 352

US proposed rule on good manufacturing practice for human food

Maintained by: United States of America
Raised by: China
Supported by:
First date raised: June 2013 G/SPS/R/71 paras. 4.3-4.4
Dates subsequently raised:
Number of times subsequently raised: 0
Relevant documents: G/SPS/N/USA/2502 G/SPS/N/USA/2503
Products covered:
Primary subject keyword: Food safety
Keywords: Control, Inspection and Approval Procedures; Food safety; Human health; International Standards / Harmonization; Equivalence; Risk assessment; HACCP Plan requirements
Status: Not reported
Date reported as resolved:

Extracts from SPS Committee meeting summary reports

In June 2013, China raised concerns with the US proposed rule on "Current Good Manufacturing Practice and Hazard Analysis and Risk-based Preventive Controls for Human Food", notified in G/SPS/N/USA/2502 and G/SPS/N/USA/2503. Part 117, Subpart C, regarding the preventive control measures put in place and monitored by operators of food enterprises, exceeded international standards without scientific justification and was therefore in contravention of the SPS Agreement. The overbroad nature of this requirement would result in reduced effectiveness and increased labour costs, thus resulting in a barrier to trade. China suggested that instead the United States should require good manufacturing practices and sanitation standard operating procedures, and furthermore employ the equivalence principle. Additionally, China took issue with the inclusion of radioactivity hazard analysis in the draft Part 117.130(b)(4), as the internationally recognized HACCP system only required the identification of biological, chemical, and physical hazards. The probability of such a hazard was extremely low and did not justify the cost of running such monitoring programs within the food industry. The United States could raise the issue of inclusion of radioactivity into the HACCP system at the meeting of the Codex Alimentarius Commission to allow for a more thorough discussion. Lastly, the requirement in the draft Part 117.126 that all food enterprises establish a written safety plan, exceeded the requirements of HACCP and the Codex standards. As such, China requested that the United States provide a scientific basis for these requirements. China suggested that a more gradual approach to the establishment of hazard analysis within food enterprises was appropriate given the varying degrees of risk associated with different products and the disparity in resources among countries.

The United States thanked China for its comments and recalled that these measures had been notified to the SPS Committee on 30 April 2013, and would be available for comment through 16 September 2013. The United States urged China and other Members, as well as any other interested members of the international community, to provide comments on the proposed rule. Comments should be submitted via the Federal eRulemaking portal, available at:, in order to ensure that those comments became part of the public record. The docket numbers for the proposed rule in the eRulemaking portal were: FDA-2011-N-0920 for preventive controls for human food, and FDA-2011-N-0921 for produce safety. Comments made outside of the public record could not be considered by the FDA in the process of finalizing the proposed rules.