Following up on news that the Food and Drug Administration’s court-imposed final rule deadlines were moved back and comment deadlines eliminated in a settlement last week, a coalition of animal feed and industry groups formally requested an extension.
Jointly the American Feed Industry Assn. (AFIA), the National Grain and Feed Assn. (NGFA), the National Renderers Assn. (NRA) and the Pet Food Institute (PFI) have asked FDA to extend the comment period 90 more days from March 31 to June 30 for the animal feed rule.
The settlement agreed to a final rule deadline of August 30, 2015, 60 days beyond the original court-imposed deadline. If FDA allowed for a 60-day extension for comments it would at least line up with the amount of time FDA got in their civil agreement, explained Dave Fairfield, director of feed services at NGFA. “Allowing 60 more days for the industry would be appropriate,” he said.
The proposed Current Good Manufacturing Practice and Risk-Based Preventative Controls for Food for Animals represents significant changes in how many in the industry would be required to do business.
“We have been working diligently to analyze the proposed rule and prepare meaningful comments that address all of the issues raised for all segments of the feed industry, but we need additional time to complete this massive undertaking,” the extension request stated.
“AFIA is pleased that a new federal district court agreement has freed FDA to make comment period changes beyond March 31. Given this was a 400-plus page major rule with only five months to review and comment and that the economic analysis has grossly underestimated the impact to the industry, it seems not only rational but extremely reasonable for FDA to offer the industry more review and comment time,” said AFIA senior vice president for legislative and regulatory affairs Richard Sellers.
The letter to FDA also explained that some of the organizations may also be requesting that FDA issue another proposed rule following its conclusion of the comments received, given the extent of changes to be recommended to the existing proposed rule.
The same groups were successfully granted additional time as a result of their first extension request in November 2013 after the rule was first introduced.
Intentional adulteration rule
FDA has proposed to exempt animal feed from its proposed rule on Focused Mitigation Strategies to Protect Food against Intentional Adulteration, published last December. AFIA, NGFA, PFI and the National Oilseed Processors Assn. (NOPA) asked for an additional 90 days on the comment period to June 30.
FDA has proposed to exempt animal feed from the rule, which the industry agrees with, explained Fairfield. Time is needed however to make a strong statement in support of the proposed exemption.
One particular component within the intentional adulteration rule is FDA’s definition of holding, which Fairfield said currently is defined in very narrow terms. Grain elevators that hold grains and oilseeds could be impacted unless the holding definition is revised to include activities routinely performed for the safe and effective storage of grain, he explained.