Opinion ID: 708113
Heading Depth: 2
Heading Rank: 3

Heading: The Individual-Compliance Standard

Text: 23 We also find that the FDA reasonably accommodated the possibility of minor, inadvertent instances of noncompliance with the NLEA's voluntary guidelines when the agency established a ninety-percent standard for individual retailer compliance for purposes of the survey required by the NLEA. The FDA certainly should be allowed leeway to establish a de minimis rule in the regulations detailing its survey methodology. See, e.g., Ohio v. EPA, 997 F.2d 1520, 1534-35 (D.C.Cir.1993) (per curiam) (The court upheld an EPA regulation that imposed a de minimis gloss on a statutory provision that required the agency to conduct periodic reviews of remedial actions taken in response to hazardous waste threats.). Thus, the issue becomes whether a ten-percent cushion is a fair proxy for a de minimis standard. Although we recognize that the proper scope of de minimis tolerance will vary from context to context, appellants provide no significant challenge to the notion that ten-percent latitude is comparable to a de minimis standard in the context of the FDA's survey. Moreover, a ten-percent standard has the advantage of providing clear guidance to surveyors, whereas a regulation that simply stated a de minimis rule would allow surveyors to fluctuate in their leniency from store to store, perhaps providing more than ten-percent leeway in some instances.