The Federal Meat Inspection Act (FMIA) and Poultry Products Inspection Act (PPIA) prohibit two product-based conditions: adulterated and misbranded. Of the two, adulterated is the more common basis for FSIS to issue a Noncompliance Record. To defend against such allegations, it is necessary to the understand to what and under what circumstances the term ‘adulterated’ applies. The term ‘adulterated’ applies to any livestock carcass, part thereof, meat or meat food product, or poultry product in nine circumstances. With the exception of Circumstance (9), the definition of ‘adulterated’ in the FMIA [21 USC 601(m)] and PPIA [21 USC 453(g)] is the same. The term ‘article’ refers to a carcass, part thereof, meat, meat food product or poultry product. An article is adulterated under one or more of the following circumstances.
The article bears or contains a poisonous or deleterious substance that may render it injurious to health; but, if the substance is not an added substance, the article is not adulterated if the quantity of the substance in or on such article does not ordinarily render it injurious to health.
- Interpret ‘injurious to health’ to mean, ‘causes or is likely to cause, damage or harm to the consumer’s health.’ A poisonous or deleterious substance that renders an article injurious to health is a food safety hazard as defined in 9 CFR 417.1.
Shiga toxin-producing Escherichia coli in raw ground beef and Listeria monocytogenes in ready-to-eat meat or poultry products are added deleterious substances. Naturally-occurring (i.e. not added) constituents in meat and poultry that are poisonous or deleterious substances are unknown.
The article bears or contains (by reason of administration of a substance to the live animal or otherwise) any added poisonous or added deleterious substance (other than one which is (i) a pesticide chemical in or on a raw agricultural commodity; (ii) a food additive; or (iii) a color additive) which may, in the judgment of the Secretary, make such article unfit for human food
- Interpret ‘by reason of administration’ to mean; if Mother Nature did not put it in, then it is administered. Interpret ‘or otherwise’ to mean an article other than a live animal. Interpret ‘unfit for human food’ to mean not injurious to health but not capable of use as human food.
- A pharmaceutical drug administered to the live animal, or a non-food chemical administered to any article, that exceed a tolerance is an added poisonous or deleterious substance which in the judgment of the Secretary make an article unfit for human food.
Circumstance 2B, C, and D:
The article: (B) is, in whole or in part, a raw agricultural commodity and such commodity bears or contains a pesticide chemical which is unsafe within the meaning of 21 USC 346a;’ (C) bears or contains any food additive which is unsafe within the meaning of 21 USC 348, or (D) bears or contains any color additive which is unsafe within the meaning of 21 USC 379e.
Provided; that an article which is not adulterated under clause (B), (C), or (D) shall nevertheless be deemed adulterated if use of the pesticide chemical, food additive, or color additive in or on such article is prohibited by regulations of the Secretary in establishments at which inspection is maintained
- Interpret ‘unsafe’ to be synonymous with ‘injurious to health.’
- The terms ‘raw agricultural commodity,’ ‘food additive,’ and ‘color additive’ have meaning within the context of the Food Drug and Cosmetic Act (FDCA), but not the FMIA or PPIA; however, 21 USC 601(r) and 21 USC 453(y) specifically adopt the meaning of these terms in the FDCA for the purposes of the FMIA and PPIA respectively.
- Interpret ‘Provided; that …’ to mean that the Secretary can deem an article adulterated by a pesticide chemical, food additive, or color additive beyond the meaning of these terms in the FDCA.
The article consists in whole or in part of any filthy, putrid, or decomposed substance or is for any other reason unsound, unhealthful, unwholesome, or otherwise unfit for human food.
- Interpret ‘filthy’ as an article characterized by disgusting extraneous material, ‘putrid’ to mean an article that is rotten, and ‘decomposed’ as describing an article separating into its constituent parts or elements or into simpler compounds
- Interpret ‘unsound’ as not healthy, ‘unhealthful’ as harmful to health, and ‘unwholesome’ as detrimental to physical well-being.
The article has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
- Circumstance 4 is the most problematic to apply because it is based on the environment around the article and not the article itself. For an article to be adulterated under Circumstance 4, two conditions must exist. (1) An article is being prepared, packed or held, and (2) the possibility that the article will come into contact with filth or a substance injurious to health exists.
- A cutting board contaminated with filth in use to prepare product capable of use as human food, or liquid dripping from overhead structures onto boxes of product capable of use as human food are prime examples. A backed-up floor drain or a leaking pesticide container leaking in a room where no product is prepared, packed, or held is not.
The article is, in whole or in part, the product of an animal, or any poultry, which has died otherwise than by slaughter.
- Interpret ‘died otherwise than by slaughter’ as describing an animal not killed for use as human food during a step in the slaughter process.
The article’s container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health.
- Specialization of the packaging materials industry, and availability of a guaranty from the packaging material supplier make Circumstance 6 nearly moot.
The article has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 348 of this title.
- Circumstance 7 is a non-issue at this point in time. Irradiated meat and poultry products are not yet commercially available.
Any valuable constituent has been in whole or in part omitted or abstracted from the article; or if any substance has been substituted, wholly or in part for the article; or if damage or inferiority in the article has been concealed in any manner; or if any substance has been added to the article or mixed or packed with the article so as to increase the article’s bulk or weight, or reduce the article’s quality or strength, or make the article appear better or of greater value than it is.
- Circumstance 8 describes ‘economic adulteration’ because the article is neither injurious to health, nor unfit for human food. The line between Circumstance 8 adulteration and misbranding can be difficult to determine. Interpret ‘valuable constituent omitted or abstracted’ as applicable to multi-ingredient products where a listed ingredient is omitted. Abstracting constituents from animal tissue capable of use as human food is impractical.
- Interpret ‘substance substituted’ as applicable to multi-ingredient products where a listed ingredient is replaced with another substance. Substituting equine muscle for beef muscle is a classic example.
- Interpret ‘damage or inferiority concealed’ as failure to meet an Acceptable Quality Level (AQL) criteria.
- Interpret added, mixed or packed to ‘increase bulk or weight,’ or ‘reduce quality or strength,’ or ‘appear better or of greater value’ as applicable to multi-ingredient products where the preparation process or composition is manipulated to create economic advantage.
The article is margarine containing animal fat and any of the raw material used therein consisted in whole or in part of any filthy, putrid, or decomposed substance.
- Circumstance 9 is a partial expression of Circumstance 3 restricted to margarine containing animal fat.