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November 14, 1980

PATRICIA ROBERTS HARRIS, et al ., Defendants.

The opinion of the court was delivered by: OBERDORFER


 The underlying facts are undisputed. FDA offices began in December, 1978, to observe the frequent presence of salmonella in shrimp imported from India. In February, 1979, the Los Angeles District Office of the FDA reported that 52 of 59 samples of Indian shrimp contained salmonella. As a result of this report, the FDA started to compile all salmonella analyses of Indian shrimp offered for import for the period October, 1978, to February, 1979. This compilation revealed that 28% of the lots sampled contained salmonella. A recommendation was consequently made to "blocklist," (i.e. automatically detain) all raw, frozen shrimp from India. See Hile Statement PP5, 6, Tab 1, Defendants' Exhibit B. In an attempt to forestall blocklisting, Indian government and trade officials had meetings with FDA officials in which they acknowledged that the salmonella in Indian shrimp had been caused by improper handling and insanitary practices within some of their processing facilities, see id. P8, Tab. 2. They requested, on February 28, 1979, that the FDA defer blcoklisting because the Indian government had begun a new sanitation program for the shrimp industry, and they invited FDA representatives to India to observe these improvements. Id. P9, Tab 2. As a result, the FDA authorized the sending of a delegation to India and deferred blocklisting, deciding instead to sample Indian shrimp offered for import on a 100% basis. Id. P10.

 An FDA delegation travelled to India between May 30 and June 8, 1979. Although Indian authorities severely restricted access to work areas, the delegation was nevertheless able to observe a number of objectionable conditions. At the shrimp processing facilities, the delegation observed unscreened, fly-infested processing areas; inadequate icing of shrimp subjected to temperatures in excess of 90 degree F.; the placement of porous shrimp-holding pans on heavily-travelled floors; and the use of pitted and cracked work surfaces covered with the residue of fecal matter from previously processed frogs. At a shrimp landing area, FDA officials observed hundreds of people, mostly barefoot and dressed in soiled clothing, milling around the dock where the shrimp were unloaded; poor icing of shrimp; and the use of bamboo baskets, which are virtually impossible to sanitize, to collect shrimp. See Roy Statement P8, Defendants Exhibit A. Following this visit, on August 24, 1979, the FDA decided to blocklist all Indian shrimp offered for import.

 Plaintiffs offered their three lots of frozen, raw Indian shrimp for import into the United States in April and May of 1979. FDA investigator collected samples from the three lots and upon examination found the presence of salmonella in each. See Gerstenberg Statement P4, Defendants' Exhibit C. The importers were all issued a Notice of Detention and Hearing, which stated that the shrimp violated § 381(a) of the Act because it "appears to contain a poisonous or deleterious substance (salmonella species)." The Notice advised the importers that they had the "opportunity to appear... to introduce testimony relative to the admissibility of the article." The Notice further advised that the importers could submit proposals for bringing the article into compliance with the Act. See Defendants' Exhibit 17.

 On November 15, 1979, the FDA issued a Notice of Refusal of Admission to each of the importers (Plaintiffs' Exhibit 7). The FDA's statement of reasons for refusing admission of plaintiffs' shrimp are contained in the following sworn affidavits submitted to the court: *fn1"

 1. The statement of Caesar A. Roy, Regional Food and Drug Director, Region II, of the FDA, who is responsible for the development, monitoring and assessment of all policy decisions implemented by FDA.He was a member of the FDA delegation which observed the shrimp landing areas and processing facilities in India. His affidavit contains a detailed report of his observations.

 2. The statement of Joseph P. Hile, Associate Commissioner for Regulatory Affairs of the FDA, who is responsible for the development and implementation of the regulatory policies adopted by the agency. He participated personally in numerous meetings connected with this controversy and also reviewed other official agency records. His affidavit narrates the discovery of salmonella in Indian shrimp prior to the blocklisting and also details the policy reasons for blacklisting shrimp. Specifically, he notes the facts that salmonella in shrimp is almost always attributable to insanitary processing procedures and therefore can be avoided by proper processing; that, by contrast, salmonella often occurs naturally in red meat and poultry, and is therefore difficult to eradicate prior to cooking; that FDA must regulate imports heavily because it is unable to regulate the processing facilities abroad; and that the economic loss blacklisting may cause importers is far outweighed by the public health concern which justifies these actions.

 3. The statement of George J. Gerstenberg, Director, New York District, Region II, of the FDA, who supervises the day-to-day enforcement of the Act in New York. This statement, based on the official records of the FDA, recites in detail the events surrounding the detention of the three batches of shrimp.

 4. The statement of John w. Hardy, Chief of the Microbiology Branch, New York Regional Laboratory of the FDA, who avers that he supervised the examination of the samples of the three batches of shrimp and that salmonella was found in each sample.

 5. The statement of Ralston B. Read, the Acting Director of the Division of Microbiology, Bureau of Foods, of the FDA, who has been involved in research on salmonella for 24 years and who has concluded from this research and from the evidence relating to the detention of Indian shrimp, that salmonella is not inherent in shrimp, but introduced by some other cause and may be injurious to health.

 6. The statement of Taylor M. Quinn, Associate Director for Compliance, Bureau of Foods, of the FDA, who participated in the formulation of the agency's regulatory policy with respect to salmonella contaminated foods, and who reviewed the documents and testimony offered by the importers in this case. He relates that this evidence, combined with the results of FDA analyses of plaintiffs' three lots of shrimp and with the ...

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