This information collection supports FDA regulations that implement minimum standards for produce offered for human consumption. The regulations set forth procedures, processes, and practices that minimize the risk of serious adverse health consequences or death, including those reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce and to provide reasonable assurances that the produce is not adulterated because of such hazards.
The information collection reflects program changes and adjustments. Although we have removed one-time burden and costs associated with implementation of the new regulations, we have added burden for recommendations included in agency guidance regarding testing for sprouts. This results in an overall reduction in responses of 92,322, but an increase in burden hours by 8,515. We also note a nominal cost increase of $104, which we attribute to calculation adjustments in rounding to whole numbers.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Recommendations in GFI (Sprouts Guidance)