REGULATORY ACTION GUIDANCE:
All mold counts are to be confirmed by a qualified analyst before consideration for regulatory action.
The following represents the criteria for direct reference seizure to *the Office of General Counsel* through Division of Compliance Management and Operations (HFC-210) and for direct citation by the District Offices if any of the following mold count criteria are met or exceeded by any code, or by the lot if no code is present:
Article Six Subsamples Examined Tomato juice Average 24% or above & all subs above 20%. Tomato Paste or Puree (refractive index as indicated AOAC Methods of Analysis) Average 45% or above, and all subs above 40%. Tomato sauce (Undiluted) Ditto Canned tomatoes with or without added tomato Average above 15% and all subs above 12%. Based on examination of juice packing medium drained from canned tomatoes. Canned tomatoes packed in tomato puree juice Average above 29% and all subs above 25%. Based on examination of packing medium drained from canned tomatoes. Pizza sauce (based on 6% total tomato solid after pulping) Average 34% and all subs above 30% Tomato soup and tomato products Average 45% or above and all subs above 40%.
Seizures involving these products must be discussed with the U.S. Department of Agriculture because some lots may have been graded by them. *E-mail* or FAX the following information to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605) and await reply before processing:
- Sample Number
- Article Involved
- Amount of Lot
- Date of Shipment
- Analytical Conclusions
Article adulterated when introduced into and while in interstate commerce, within meaning of 21 U.S.C. 342(a)(3), in that it consists wholly or in part of a decomposed substance by reason of presence therein of decomposed tomato material.
The following represents the criteria for recommending legal action to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605):
Article Six Subsamples Examined Tomato catsup Average 55% or above Tomato powder (except spray dried) Average of 45% or above and all subs above 40%. Tomato powder (spray dried) Average 67% or above
Note: Tomato Powder - check to determine if it has been spray dried. (See attachment).
Tomato powder is produced by dehydrating concentrated tomato pulp. In preparing the powder for mold counting the moisture content is disregarded and a dilution of water is made to give a mixture with approximately the tomato solids content of the standardized preparation for mold count of tomato puree or paste, namely, 8.5 percent.
Identification of powder as spray-dried product:
Mold counts of spray-dried tomato powder show significantly higher counts than the paste from which it is made due to breakage of mold hyphae aggregates. Use following procedure to determine whether powder represents a spray-dried product.
To determine microscopically whether the product has been produced by spray-drying, suitable mount a small portion on a microscope slide in mineral oil or other non-aqueous mounting medium and examine microscopically at 100-200X. Spray-dried particles are translucent and contain air bubbles and numerous small granules within the particles. The shape of the particles ranges from spherical to elongate to irregular with rounded outlines and essentially no sharp angles. In the rehydrated powder, practically no intact tomato cells are evident. Drum-dried or similarly processed powder or flakes are characterized by irregular-shaped particles with angular outline and practically no embedded air bubbles.
Examine spray-dried tomato powder for HMC by AOAC 44.211. 14th ed.
*Material between asterisks is new or revised*
Revised: 3/1/82, 7/1/83, 9/1/84, 1/16/85, 3/95, 8/96, 5/2005