Tolerance Levels, Action Levels, and Regulatory Limits | jgersen | February 11, 2016

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Tolerance Levels, Action Levels, and Regulatory Limits

by jgersen Show/Hide
  1. 2 Show/Hide More Community Nutrition Institute v. Young
    Original Creator: jgersen
     

    1. Legislative Rules.  As the court notes, section 553 of the Administrative Procedure Act requires certain minimal procedural steps prior to the issuance of a new rule of regulation.  In short, the agency must publish a Notice, take Public Comments, and issue a Concise Statement of Basis and Purpose accompanying the final rule.  This process is known as “informal rulemaking” because it does not utilize the Formal Rulemaking procedures specified in sections 556 and 557 of the APA, procedures that closely resemble a judicial trial with the presentation of evidence, cross-examination, and the like.   Section 553 contains an exception for, inter alia, “interpretative rules and general statements of policy.”  Because most rules also interpret, courts have been left to struggle with whether a particular agency document is a policy statement or interpretative rule that is exempt from notice and comment requirements or a “substantive” or “legislative” rule for which such procedures are required.  Is the FDA’s action level properly classified as a legislative rule or an exempt interpretation or policy statement? 
    2. Agencies and the APA. The APA contains a set of default procedural requirements for administrative agencies.  If an agency’s organic or creating statute (the statute granting the agency legal authority) says nothing about how the agency may exercise its power, then the APA applies.  Sometimes, however, Congress builds specific procedural requirements into an agency’s organic statute.  In that case, the specific requirements trump the default requirements.  Such is the case with the National Labor Relations Act (NLRA) and the FDCA.   
    3. Blending In Part II of the court’s opinion, it considered the blending problem. FDA has sometimes granted exemptions so that contaminated corn can be blended with uncontaminated corn to bring the total level of aflatoxin contamination below the action level.  Consumer groups argued that the corn is properly deemed adulterated.  The court agreed, but concluded that FDA maintains discretion about whether to initiate an enforcement proceeding for any adulterated food.  Because decisions about whether to enforce a particular legal obligation against a particular party is nearly unreviewable by courts, the legal conclusion that blended corn is adulterated carried no legal remedy for petitioners. Is there anything to stop FDA from deciding to never initiate enforcement proceedings against foods all parties agree are adulterated?  If not, is there something amiss with the legal regime?  Or, is this simply an inevitable feature of agency discretion about when and against whom to enforce legal obligations?
    4. Judge Starr. What is Judge Starr’s disagreement with the majority? What doctrinal test does he propose to distinguish substantive rules from policy statements? Is his test easy to administer than the smog that the majority offers? 
    5. The FDA & the APA. The FDA has continued to rely on guidance documents—facially non-binding policy statements and interpretative rules to announce agency positions and its interpretation of what is required of regulated parties.  Is policy by guidance desirable?  How ought we analyze these questions in the context of food policy?  Consider that conditions in the food industry are often changing rapidly and guidance offers the agency flexibility and speed when necessary.  By the same token, because guidance is generally issued without a transparent process of public notice, comment, and agency response, it means agency views often reflect limited input from the public. Does the majority in CNI II exacerbate or ameliorate this problem?    
    Notes:
    <p>1. Prosecutorial Guidelines. After the D.C. Circuit held that action levels were legislative rules and therefore had to be promulgated using notice-and-comment, the <span class="caps">FDA</span> revised its regulations, declaring that action levels were to be used as prosecutorial guidelines. The result is that the action levels remain influential, but are not binding on either the agency or industry. See Action Levels for Added Poisonous or Deleterious Substances in Food, 55 Fed. Reg. 20782 (May 21, 1990).</p> <p>2. Regulatory Limits. With tolerance levels requiring extensive procedural formality and action levels reduced to non-binding prosecutorial guidelines, <span class="caps">FDA</span> sought to craft a new tool: &#8220;regulatory limits.&#8221; Regulatory Limits are promulgated using informal rulemaking (notice-and-comment rulemaking). They are therefore binding and susceptible of review in federal court. Is there any advantage of to the regulatory limit? Is there any point to having action levels for prosecutorial guidelines and also binding regulatory limits?</p>
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February 11, 2016

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Jacob Gersen

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