We are pleased that Dr. Michael Fisher has joined the FTCLDF website as a monthly contributor. Dr. Fisher is a retired United States Department of Agriculture (USDA) Food Safety and Inspection Services (FSIS) veterinarian, bringing decades of experience enforcing FSIS regulations during the slaughter and processing of animals for which the USDA provides inspection services. Dr. Fisher is thrilled to bring you his expertise and guidance to help you navigate the regulatory compliance. His goal is for small, USDA-inspected meat processors to succeed and to understand how to best maintain compliance and reduce regulatory issues.
In 1991, I entered a graduate program in veterinary pathology. I knew the pathological conditions. Recognizing them under a microscope took practice, but I got there. The same is true of the term “adulterated,” arguably the most significant term in food law.
With the exception of Circumstance (9), the definition of “adulterated” in the FMIA [21 USC 601 (m)] and PPIA [21 USC 453(g)] are 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.
Adulterated Circumstances
Circumstance (1): It bears or contains any poisonous or deleterious substance which may render it injurious to health [34 Stat 770], but in case the substance is not an added substance, such article shall not be considered adulterated under this clause if the quantity of such substance in or on such article does not ordinarily render it injurious to health. [52 Stat 1046]
- The article bearing or containing the poisonous or deleterious substance is adulterated if consumption is injurious to health. Interpret “injurious to health” to mean “causes or is likely to cause, damage or harm to the consumer’s health.” The substance can be added or not added. Raw ground beef that bears or contains Shiga toxin-producing Escherichia coli is a prime example.
- The article bearing or containing the poisonous or deleterious substance is not adulterated if the poisonous or deleterious substance is a naturally-occurring constituent (i.e. not added) and the quantity present is not injurious to health. Many edible plants bear or contain naturally-occurring poisonous or deleterious substances in a quantity not injurious to health. Glycoalkaloids in potatoes are a prime example. Examples in muscle tissue are unknown.
Circumstance (2) has four clauses and can be confusing.
(2)(A) It bears or contains (by reason of administration of any 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. [81 Stat 584]
- The article is adulterated if (1) the poisonous or deleterious substance is not a pesticide chemical in or on a raw agricultural commodity, food additive, or color additive and, (2) in the judgment of the Secretary, makes the article unfit for human food. A drug residue caused by administration of a pharmaceutical drug to the live animal that, in the judgment of the Secretary is unacceptable, is a prime example.
- Interpret “administration” to mean if Mother Nature did not put it in, then it is administered. The meaning of “live animal” is clear, but what does “or otherwise” mean? “Or otherwise” means anything capable of use as human food that is not a live animal. Interpret “unfit for human food” to mean that the article is adulterated but not injurious to health.
(2)(B) It 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. [68 Stat 511]
(2)(C) It bears or contains any food additive which is unsafe within the meaning of 21 USC 348. [72 Stat 1784]
(2)(D) It bears or contains any color additive which is unsafe within the meaning of 21 USC 379e: [74 Stat 397].
- Clause (B), (C), or (D) are provisions of the Federal Food, Drug, and Cosmetic Act (FDCA) and do not apply because meat and poultry products are exempt from the provisions of the FDCA. However, the following provision in the 1967 and 1968 amendments to the FMIA and PPIA respectively, resolves this problem.
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 under this subchapter [81 Stat 584].
- The FMIA and PPIA define “pesticide chemical,” “food additive,” “color additive,” and “raw agricultural commodity” to have the same meanings as the FDCA. Essentially, Congress applied the meaning of clause (B), (C), or (D) to meat and poultry products, but not the actual clauses. Interpret “unsafe” as synonymous with “injurious to health.” Like I said, confusing.
Circumstance (3): It consists in whole or in part of any filthy, putrid, or decomposed substance [34 Stat 770] or is for any other reason unsound, unhealthful, unwholesome, or otherwise unfit for human food.
- This language is free from doubt or ambiguity. If taste, color, odor, or feel can detect any amount of a filthy, putrid, or decomposed substance, the article is adulterated. Contamination with visible feces, hair, or ingesta is a prime example.
Circumstance (4): It 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. [52 Stat 1046]
- This language is often misinterpreted for two grammatical reasons. Unlike the other eight circumstances, which rest on objective transitive verbs, Circumstance (4) rests on the subjective auxiliary verb “may.” Circumstance (4) uses a comma to separate two independent clauses linked with a coordinating conjunction. Circumstance (4) is best understood if expressed as two independent statements. (1) “It has been prepared…whereby…contaminated with filth” and (2) “It has been prepared…whereby…rendered injurious to health.”
- 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 T-bone steak prepared on a cutting board contaminated with exudate or the contents of an overhead pipe leaking onto a box of pork loins, are prime examples. A backed-up floor drain in the basement where no product is prepared, packed, or held is not.
Circumstance (5): It is, in whole or in part, the product of an animal, or any poultry, which has died otherwise than by slaughter [34 Stat 770].
- This language is free from doubt or ambiguity. The death of the animal from which the article was prepared, must be directly related to its conversation to human food. Dead animals are unfit for use as human food. Product prepared from an animal that was already dead when presented for slaughter is the only example.
Circumstance (6): Its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health. [52 Stat 1046]
- This language is free from doubt or ambiguity. Packaging materials entering the official establishment accompanied a guaranty from the supplier stating that the material’s intended use complies with the FDCA and all applicable food additive regulations ensure the product is not adulterated under Circumstance (6).
Circumstance (7): It 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.
- This language is free from doubt or ambiguity, and a non-issue at this point in time. Irradiated meat and poultry products are not yet commercially available. Maybe in my grandchildren’s lifetime.
Circumstance (8): Any valuable constituent has been in whole or in part omitted or abstracted therefrom; or if any substance has been substituted, wholly or in part therefor; or if damage or inferiority has been concealed in any manner; or if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is [34 Stat 770 and 52 Stat 1046].
- Circumstance (8) is described as “economic adulteration” because the article is neither injurious to health, nor unfit for human food. The criteria “omitted, abstracted, substituted, and added” are reasonably objective. The criteria “damage or inferiority” are not. In 1997, FSIS eliminated all Acceptable Quality Level (AQL) criteria not codified in the CFR [62 FR 45016], which eliminated existing damage criteria and relegated determinations of adulteration to the realm of individual opinion.
Circumstance (9): It 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.
That was a lot of material to work through. Defending your process against allegations of adulteration-based noncompliance depends on your ability to prove that none of the applicable circumstances described applies to your product or process. As always, if you have a question, please use the Contact Us link and ask.
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