The opinion of the court was delivered by: BARTELS
On July 22, 1971 the claimant, Fruitful Valley Sun, a California corporation, sold and subsequently shipped 900 cases of canned peaches, each containing twelve cans of peaches, to Louis Ender, Inc., in New York. On August 23, 1971, the peaches having arrived in New York, ninety-six of the cans were appropriated as a sample, of which thirty-five were inspected for test purposes by the United States Food and Drug Administration ("FDA"). After laboratory analysis the FDA concluded that the peaches were contaminated and thereupon placed them under embargo in the warehouse of Louis Ender, Inc. in Brooklyn, New York. The plaintiff, United States of America, now brings this libel in rem under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., for the condemnation of the 900 cases of peaches. Jurisdiction is based on 21 U.S.C. § 334(a)(1).
At the trial evidence was offered to show that three tests were made on the peaches, two by the United States and one by the claimant. The first test was made on behalf of the United States, on August 30, 1971, by Thomas Schwarz, an entomologist for the FDA, who examined thirty-five of the ninety-six cans appropriated by the FDA as samples. He tested each of the thirty-five cans by first draining the contents of the can through a sieve and by rinsing the peach halves with distilled water, and he then filtered the drained juice and rinse water through filter paper thereby collecting on the paper all solid particles. As the next step he microscopically examined the residue for insect larvae and insect excreta and tabulated and recorded the results according to the manufacturer's can code numbers stamped on each can. In the ten cans with the code number NP718682 Schwarz found that five of them contained a whole moth larva and that nine of them contained insect excreta pellets with a range of three to thirty-seven pellets and an average of 11.9 pellets per can. He found a whole moth larva in eleven of the twenty-five cans stamped with the number NP72GN22, and in four of the cans he found two larvae. In addition he found in twenty-two of the twenty-five cans insect excreta with a range of one to sixty-seven pellets and an average of 18.9 pellets per can. The libel stems from this information.
On March 30, 1972 the Commissioner of Food and Drugs published for the first time in 21 C.F.R. § 128.10 a notice announcing that the FDA had established maximum acceptable tolerance levels for natural and unavoidable defects in food not hazardous to health, copies of which levels were obtainable upon request. Until then these unpublished tolerance levels were employed for the purpose of enabling the FDA to determine whether or not to file a libel and have served the same purpose since publication. For canned peaches the defect tolerance level is "Average 5% wormy or moldy fruit by count or 4% if a whole larva is found in 20% of the cans." Some time prior to November, 1972, the claimant requested and received a copy of the defect tolerance levels referred to above.
In November, 1972 the claimant requested, for testing purposes, a duplicate set of sample cans of peaches and, accordingly, the FDA on January 8, 1973, shipped to the claimant thirty of the ninety-six sample cans. On July 5, 1973, at the request of the claimant, Dr. York, a biochemist engaged in extension food technology at the University of California at Davis, tested each of the thirty cans of peaches in the following manner. He first tested each can separately by filtering the juice through filter paper under vacuum and microscopically examining the remaining fragments for insect fragments and insect larvae. He then washed each peach half with distilled water, added back the water to the peaches, and macerated the entire mixture in a mechanical blender. After this procedure he put the blended mixture into a flask and, in order to isolate all animal parts, he then, pursuant to the "Wildman Trap Flask Method," added a light mineral oil which coated all such animal parts causing them to float to the top. Finally he decanted the mineral oil, filtered it through filter paper, and microscopically examined the remaining fragments. From this method Dr. York was able to count every insect fragment and he found through his tabulations that there were a total of ten insect fragments in eight of the cans tested. No examination of the individual peach halves for worminess or moldiness was made prior to their maceration although both claimant and Dr. York had copies, at the time, of the FDA tolerance levels for natural and unavoidable defects.
Because Schwarz's August 30, 1971 test on the thirty-five cans of peaches did not include an examination of the peach halves for worminess, as required by the published defect tolerance levels, he was instructed to test fifteen additional cans. On February 4, 1974 he individually tested each of the fifteen cans by draining the juice through a sieve, washing the peach halves with distilled water, placing the juice and rinse water in a flask, and, following the "Wildman Trap Flask Method," adding heptane to the flask which coated all animal parts and caused them to float to the top. He then drained off the heptane, passed it through a filter paper, and microscopically examined the remaining particles for insect larvae. This examination revealed that six of the fifteen cans (40%) contained a total of nine whole insect larvae or their equivalent but Schwarz did not tabulate every insect fragment but rather only complete heads whether or not attached to a body. Schwarz also microscopically examined each peach half for evidence of the past presence of an insect either on or in the peach halves such as tunnelling, embedded insect fragments, and insect excreta. Thirteen of the one hundred and forty-three halves (9%) were found to have such evidence.
On May 1, 1974 the claimant, in order to retest the peaches in conformity with the published defect tolerance levels as interpreted by the FDA, requested a second set of sample cans which was denied. Because of this denial claimant moved, at the trial, to dismiss the libel which was also denied on the ground that there was no statutory authority requiring the delivery of two sets of sample cans to the claimant and for the further reason that the claimant was not misled since at the time of its first test it had in its possession the defect tolerance levels.
Under 21 U.S.C. § 334(a)(1) the United States has the right to condemn any article of food, including peaches, which is adulterated and is shipped in interstate commerce.
Section 342(a)(3) of Title 21 defines "adulterated" as:
"A food shall be deemed to be adulterated -- (a) . . . (3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food."
At the trial it was established by a preponderance of the evidence that the peaches in question did contain matter constituting "filth" as that term is used in the statute. The results of the two tests performed by Schwarz and the one performed by Dr. York all reveal that the cans of peaches are contaminated by varying amounts of insect larvae and insect fragments. Since it has been long established, and the parties agree, that insects, insect larvae, and insect fragments are "filth" within the meaning of 21 U.S.C. § 342 (a)(3), United States v. Cassaro, Inc., 443 F.2d 153 (1st Cir. 1971); United States v. 1,500 Cases More or Less, Tomato Paste, 236 F.2d 208 (7th Cir. 1956); Golden Grain Macaroni Co. v. United States, 209 F.2d 166 (9th Cir. 1953); United States v. Capital City Foods, Inc., 345 F. Supp. 277 (D.N.D. 1972); United States v. 133 Cases of Tomato Paste, 22 F. Supp. 515 (E.D. Pa. 1938), the only remaining questions raised by the claimant are: (1) the correctness and adequacy of the testing methods used by Schwarz, and (2) the amount of "filth", in the form of insect larvae and insect fragments required for a violation of 21 U.S.C. § 342 (a)(3).
At the trial the claimant attacked the tests employed by the United States in determining the existence of "filth" as that term is used in 21 U.S.C. § 342(a)(3). The parties agree that the entire sample of ninety-six cans taken by the FDA from the nine hundred cases of canned peaches were selected at random and were fairly and reasonably representative of the defendant peaches. There was no evidence that the form of testing or the methods used were either improper or incorrectly performed by Schwarz who was a qualified expert with much experience in examining food for insect contamination. The claimant claims that Schwarz's ...