The arrogance of the statement by AMI deserved your pointed and accurate response.

I just wish I could find a way to quit eating meat until you win the day. Problem is the poison is everywhere...peanuts, lettuce, sprouts, deli meats, chicken. How depressing!

Dear Mr. Marler,

You stated on June 1st on your main blog the FDA already considers Escherichia coli O145 an adulterant.

Please tell me when the FDA decided to consider Escherichia coli O145 an adulterant. I would greatly appreciate being told the location of the document that states this policy.

The method FDA currently uses to test food samples for
Escherichia coli O157:H7 states FDA does not have a regulatory position on non-O157 STECs. I sent you this reference several months ago. The Web address of the method and the regulatory statement is repeated below.

I ask you this question because yesterday a formal work
instruction (equivalent to a SOP) was made official in my laboratory. The document states my facility will not pursue screening and isolation of non-O157 STEC strains except when an outbreak of foodborne illness requires such testing.

Use of the FDA method I mentioned in several FDA laboratories has been generating several difficulties for the detection and isolation of Escherichia coli O157:H7 and non-O157 STEC.

I do not know what methods IEH Laboratories used for your non-O157 STEC project. I would be very interested in seeing the protocols because the organization has been successful with the methods it has been using, procedures that may be superior to the FDA BAM protocol.

Thank you for continuing your excellent reporting. I learn more about food outbreaks from your blog than most of the communications I receive from the Agency. Keep up the great work.

My Response:

Good Morning – perhaps the fact that, as you say “[t]he method FDA currently uses to test food samples for Escherichia coli O157:H7 states FDA does not have a regulatory position on non-O157 STECs,� and that the FDA has never made a “this is considered and adulterant and this is not considered an adulterant,� like Mike Taylor’s pronouncement of FSIS policy in 1994, and the fact that recalls are done when FDA regulated product is contaminated with a variety of pathogens including Salmonella and non-O157’s (when found), things NOT done by FSIS except E. coli O157 and listeria in RTE foods, and recently an occasional antibiotic-resistant Salmonella case, gave me the clear impression that FDA did not make the artificial ““this is considered and adulterant and this is not considered an adulterant,� distinction. Was it wishful thinking on my part? Or, is it a proper reading of:

Sec. 402. [21 USC §342] Adulterated Food - A food shall be deemed to be adulterated—  1(a) Poisonous, insanitary, or deleterious ingredients. (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; [or]  2 (2)(A)  3if it bears or contains any added poisonous or added deleterious substance (other than a substance that is a pesticide chemical residue in or on a raw agricultural commodity or processed food, a food additive, a color additive, or a new animal drug) that is unsafe within the meaning of section 406; or (B) if it bears or contains a pesticide chemical residue that is unsafe within the meaning of section 408(a); or (C) if it is or if it bears or contains (i) any food additive that is unsafe within the meaning of section 409; or (ii) a new animal drug (or conversion product thereof) that is unsafe within the meaning of section 512; or (3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food; or (4) if 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; or (5) if it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter; or (6) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (7) if 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 409.

Am I missing something? Please tell me that FDA does not actually take the position that FSIS does on pathogenic non-O157’s (or Salmonella for that matter)?

On some of the more technical issues of testing, I will defer to Dr. Samadapour (who is presently doing testing for the FDA and industry on a variety of pathogens). Attached is his powerpoint he recently presented to FSIS.

Thanks for the email. More “food� for thought and more “shit� to worry about.