The US Food and Drug Administration (FDA) has denied the request for an extension on the comment period for the FSMA animal food rule. The American Feed Industry Association (AFIA) has responded to the denial, with Senior Vice President of Legislative and Regulatory Affairs Richard Sellers expressing disappointment.
"We are disappointed FDA did not grant the industry more time to review the 'Current Good Manufacturing Practice and Hazard Analysis and Risk-based Preventive Controls for Food for Animals' proposed rule provided the agency themselves was given an extension by the courts," said Sellers. "FDA had more than two years to write the animal food rule while allotting the animal feed industry only five short months to review and submit comments on the rule. This faults in comparison to the human food rule, which had an 11-plus month comment period timeline."
The FDA had already granted an extension beyond the original 120-day comment period, giving the industry an extra 33 days, to March 31, 2014. "FDA believes this total period of 153 day has provided ample opportunity for stakeholders to comment on the proposed rule," said the FDA. "In addition, FDA is under a consent decree issued by the Federal District Court for the Northern District of California Oakland Division...to publish the final rule for preventative controls for food for animals by August 30, 2015. As such, we need sufficient time to review, analyze and respond to the comments received, draft the final rule and move the rule forward through clearance to publish by the court-ordered deadline."
According to Sellers, AFIA does not predict FDA will move forward with a re-proposal of the rule as there is not enough time given the court-mandated timeline. "However, FDA stated it will publish revised language for the proposed rule, which was a deciding factor in their denial of a second extension to the comment period deadline," said Sellers. "AFIA will be submitting comments by the March 31 deadline and has informed the agency that we will continue to filter feedback and comments after that date due to the enormity of the rule."
"We are disappointed FDA did not grant the industry more time to review the 'Current Good Manufacturing Practice and Hazard Analysis and Risk-based Preventive Controls for Food for Animals' proposed rule provided the agency themselves was given an extension by the courts," said Sellers. "FDA had more than two years to write the animal food rule while allotting the animal feed industry only five short months to review and submit comments on the rule. This faults in comparison to the human food rule, which had an 11-plus month comment period timeline."
The FDA had already granted an extension beyond the original 120-day comment period, giving the industry an extra 33 days, to March 31, 2014. "FDA believes this total period of 153 day has provided ample opportunity for stakeholders to comment on the proposed rule," said the FDA. "In addition, FDA is under a consent decree issued by the Federal District Court for the Northern District of California Oakland Division...to publish the final rule for preventative controls for food for animals by August 30, 2015. As such, we need sufficient time to review, analyze and respond to the comments received, draft the final rule and move the rule forward through clearance to publish by the court-ordered deadline."
According to Sellers, AFIA does not predict FDA will move forward with a re-proposal of the rule as there is not enough time given the court-mandated timeline. "However, FDA stated it will publish revised language for the proposed rule, which was a deciding factor in their denial of a second extension to the comment period deadline," said Sellers. "AFIA will be submitting comments by the March 31 deadline and has informed the agency that we will continue to filter feedback and comments after that date due to the enormity of the rule."
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