Adulteration | jgersen | February 11, 2016


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by jgersen Show/Hide
The combination of the FDCA, FMIA, and PPIA prohibit the introduction of food that is adulterated. Like the term misbranded, adulterated is a legal term of art that corresponds only tangentially to the colloquial use of the term. Food is adulterated if (1) it contains a harmful substance posing a safety risk; it contains an added substance during production and exceeds acceptable levels; (3) it contains a substance that has been intentionally added to the food but has not been approved by an agency, or (4) it has been handled in unsanitary conditions that create a risk of contamination posing a safety risk. EDIT PLAYLIST INFORMATION DELETE PLAYLIST

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  1. 1 Show/Hide More Composition
    Original Creator: jgersen

    Because of the way federal law defines adulteration, an initial question in determining whether a food is adulterated is whether it contains a substance that is either added to the food or inherent in the food. A substance is a material that comprises a food product. Consider FDCA section 402(a)(1), 21 U.S.C. § 342(a)(1).

    If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health.

    That is, merely because a food contains a poisonous or deleterious substance, it is not necessarily adulterated. If the substance naturally inheres in the food, then it is only adulterated if it satisfies the “ordinarily injurious to health” standard. If the substance is “added” then the food is adulterated it satisfies the “may render injurious” standard which establishes adulteration by proof of the possibility of harm.

    These differences are more than merely semantic. The may-render-injurious standard takes into account especially vulnerable groups like children, the elderly, or those allergic. The ordinarily-injurious-to-health standard does not, focusing instead on the effect of the substance on the food-consuming public in general.

  2. 2 Show/Hide More Added Substances
    Original Creator: jgersen
    The FDCA does not define added. Because the burden the FDA must carry is higher under the may-render-injurious standard, obviously the agency often prefers to use the ordinarily-injurious-to-health standard associated with “added” substances. FDA regulations define added broadly. A substance is added if it is not an inherent constituent of the food; is the result of environmental, agricultural, industrial, or other contamination; or if the natural amount of the inherent substance has been increased to abnormal levels by mishandling or other intervening acts. See 21 C.F.R. 109.3. Must the presence of a substance be attributable in whole or in part to an act of man? The following cases offer conflicting approaches to this question.
    1. 2.1 Show/Hide More United States v. Anderson Seafoods, Inc.
      Original Creator: jgersen
      1. Section 342(a)(1) of the Act provides:  A food shall be deemed to be adulterated —(a)(1) if it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health.
      2. As the Court says, the statute does not define “added substance” but much turns on this term. The evidentiary showing that the FDA must make to succeed in an enforcement provision turns on it. If a substance is an added substance, then the Agency need show only that it “may render [the food] injurious to health” in order to regulate consumption of the food containing the substance. The “may render” standard has been interpreted to mean that there is a reasonable possibility of injury to the consumer. If a substance is not “added” then the Agency must make a higher showing, that the substance would “ordinarily render [the food] injurious to health.” Why would such a legal regime make sense?
      3. The government’s view in the cases was that an “added substance” is one that is not “inherent.” There are two types of “poisonous or deleterious” substances on this view. Those that are “naturally occurring” are those that are not introduced into the food as a result of environmental, agricultural, industrial, or other contamination. An “added poisonous or deleterious substance” is not “natural occurring.” Yet when a naturally occurring poisonous or deleterious substance increases beyond a certain level, it then becomes an “added poisonous or deleterious substance.” On this view all mercury in fish is an added substance.
      4. Anderson’s theory was that a substance is not an added substance unless it is proved to be present as a result of the direct agency of man. And, only that amount of a substance the lineage of which can be so traced is “added.” If some mercury in swordfish occurs naturally, and some is the result of man-made pollution, only that percentage of the mercury in fish proved to result directly from pollution is an added substance. There is something intuitively appealing about this theory in that is corresponds to a common-sense view of the term added.
      5. Under the court's theory, if a de minimis amount of the mercury in swordfish is shown to result from industrial pollution, then all of the metal in the fish is treated as an added substance and may be regulated under the statute's “may render injurious” standard. The court was ultimately convinced by this theory. Was the court convinced as a matter or policy or law or both? Is it a concern that under this theory, materials naturally occurring and that naturally occurred in food are magically transformed into an “added poisonous or deleterious substance”? As the court noted, the House Report on the 1906 statute said that “added” meant “attributable to the acts of man” and “not-added” meant attributable to the events of nature.” H.R. Rep. No. 2118, 59th Cong., 1st Sess. 6, 7, 11 (1906).   Senator Heyburn, discussing this issue offered a sensible defense of the Act’s framework. Simply because a substance that could be harmful exists in a food ought not create immunity for someone who adds more of that poisonous or substance to the food.
      6. United States v. Anderson Seafood forced the FDA and the courts to confront the relationship between food law and environmental law. We consider this issue more directly elsewhere in this book. Note, however, this specific example of the more general problem. Mercury is a naturally occurring element that is present in the environment, in plants, and in animals. Various industrial activities like utility plants and waste incinerators add significant mercury to the air, ultimately water, and then small fish, which are eaten by larger fish. This process is known as “bioaccumulation” in the larger fish, and it is why larger fish are generally more dangerous to eat than smaller ones. Humans who infest mercury are at greater risk of reproductive difficulties and nervous system disorder. See EPA’s Mercury Factsheet, available at How should food law respond to environmental law’s failure to adequately control mercury emissions or vice versa? Precluding mercury from ever being considered an added substance would allow for the consumption of fish with dangerously high levels of mercury simply because some mercury is present in fish naturally. Yet, isn’t it likely that this sort of environmental addition of a substance—not by the producer or seller of food—but by industrial activity in general isn’t quite what the drafters of the FDCA had in mind when they used the term “added substance”? If so, then should the court update the FDCA? Should the legislature? What is the relevance of changing factual circumstances that render an old legal framework insufficient to address a core food-related danger?
    1. 3.2 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?    
      <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>
    1. 4.1 Show/Hide More United States v. Forty Barrels and Twenty Kegs of Coca Cola
      Original Creator: jgersen
      1. Adulteration in a special sense. The court notes that “adulteration” is used in the statute in “a special sense.” In what sense does the Court think adulteration is used in a special sense? The Court seems to distinguish between two sorts of foods. For naturally occurring foods, like a banana, adulteration means the introduction into the banana of something harmful. For non-naturally occurring foods like coca-cola, however, what does it mean to be adulterated? If a food is manufactured from a set of ingredients, how can it be deemed adulterated because one of those ingredients is included? Prior to its inclusion, the drink was not Coca-cola. After its addition, the drink was coca-cola, but it was not adulterated because nothing new had been added after it became coke. In any event, such was Coke’s argument. The Supreme Court, however, disagreed. A manufactured food product may be adulterated if a deleterious or harmful substance is added as part of the manufacturing product. <br /> 2. Added v. Inherent. The adulteration doctrine has developed to distinguish between substances inherent in a food and substances added to food. The same food may be adulterated when a substance is added to it, but not adulterated when the same substance occurs naturally as part of the food product. As the Court said, “[y]ou can extract poison from grain or its products and when it is extracted it is a deadly poison; but if you leave that poison as nature embodied it in the original substances it is not a dangerous poison or an active agency of poison at all.” Why does it make sense to hinge legality on whether a substance is inherent in a food or whether it is added to a food? Would not a more rational system simply ask whether the substance was harmful or injuries to human health, whether inherent or added? <br /> 3. Is caffeine added? Although the Court had little trouble concluding that caffeine is an added substance, consider the difficulty that processed foods or manufactured foods generate for the food safety regime. When a food is processed together from a set list of ingredients and has only a trade name like coca-cola, the company has a sensible argument that until all the ingredients are mixed together, it is not coke. And after all the ingredients have been mixed, nothing has been added. <br /> 4. Is caffeine a poisonous or deleterious substance? As the Supreme Court noted, the government presented evidence that caffeine is a poisonous or deleterious substance. The industry presented evidence that caffeine is safe. That question, however, is for the jury. <br /> 5. Caffeine today. One hundred years later, the <span class="caps">FDA</span> is once again inquiring whether caffeine is safe. After concluding that food products mixing alcohol and caffeine are not safe, <span class="caps">FDA</span> is inquiring whether caffeinated chewing gum is dangerous. One piece of caffeinated gum has the same amount of caffeine as half a cup of coffee. After initial <span class="caps">FDA</span> investigation, several chewing gum companies withdrew the product.

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