In Defense of Animals v. United States Department of Agriculture et al

MOTION for Summary Judgment

D.D.C.August 3, 2005

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA IN DEFENSE OF ANIMALS, ) ) Plaintiff, ) ) v. ) ) THE UNITED STATES DEPARTMENT ) OF AGRICULTURE, ) ) Civil Action No. 02-0557 (RWR) Defendant, ) ) and ) ) LIFE SCIENCES RESEARCH, INC., ) ) Intervenor-Defendant. ) ) DEFENDANT'S RENEWED MOTION FOR SUMMARY JUDGMENT Defendant United States Department of Agriculture (USDA), by its undersigned attorneys, respectfully moves the Court, pursuant to Rule 56 of the Federal Rules of Civil Procedure, for summary judgment on the grounds that no genuine issue of material fact exists and that it is entitled to judgment as a matter of law. In support of this motion, the Court is respectfully referred to the Declaration of Lesia M. Banks, Assistant Director, Freedom of Information Staff, Legislative and Public Affairs Division, Animal and Plant Health Inspection Service, USDA; to Defendant's Supplemental Statement of Material Facts as to Which There is No Genuine Issue; to the Memorandum of Points and Authorities in Support of Defendant's Renewed Motion for Summary Judgment, and Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 1 of 42 -2- to Defendant's Second Vaughn Index, all of which are filed herewith, as well as to the entire record herein. Respectfully submitted, KENNETH L. WAINSTEIN (D.C. Bar #451058) United States Attorney R. CRAIG LAWRENCE (D.C. Bar #171538) Assistant United States Attorney Dated: August 3, 2005 ANNE D. WORK (D.C. Bar #376314) Attorney-Advisor Office of Information and Privacy United States Department of Justice Flag Building, Suite 570 Washington, D.C. 20530-0001 (202) 616-5494 Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 2 of 42 1 The first and second declarations of Hugh Gilmore [hereinafter First Gilmore Decl. and Second Gilmore Decl.] filed December 12, 2002, and March 21, 2003, respectively; the Declaration of Michael Caulfield, [hereinafter Caulfield Decl.], General Manager of Huntingdon Life Sciences, Inc. filed March 21, 2003; and the Declaration of Francis Keyser, Investigator, Investigations and Enforcement Services division of the Animal and Plant Health Inspection Service, USDA, filed March 21, 2003, (continued...) UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA IN DEFENSE OF ANIMALS, ) ) Plaintiff, ) ) v. ) ) THE UNITED STATES DEPARTMENT ) OF AGRICULTURE, ) ) Civil Action No. 02-0557 (RWR) Defendant, ) ) and ) ) LIFE SCIENCES RESEARCH, INC., ) ) Intervenor-Defendant. ) ) DEFENDANT'S SUPPLEMENTAL STATEMENT OF MATERIAL FACTS AS TO WHICH THERE IS NO GENUINE ISSUE, PURSUANT TO LOCAL RULE 7(h) Pursuant to Local Civil Rule 7(h), defendant United States Department of Agriculture (USDA) submits the following supplemental statement of material facts as to which there is no genuine issue: 1. Incorporated by reference herein is Defendant's Statement of Material Facts as to Which There is No Genuine Issue, Pursuant to Local Rule 7(h), filed December 12, 2002.1 Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 3 of 42 -2- 1(...continued) provide a full chronology of the administrative processing of the records requested by plaintiff. 2. The records remaining at issue consist of three categories: I) Final Test Reports and Related Records (124 pages withheld in full), Clinical Observation Raw Data Reports (121 pages withheld in full), and Interim Test Reports (twenty-two pages withheld in full); II) Necropsy and Postmortem Examination Reports (twenty-three pages withheld in full), Viability Records (397 pages released in part and fifty-eight pages withheld in full), and Veterinary Treatment Request and Logs (twenty pages released in part and ninety-four page withheld in full), including, in addition, observations sheets (twenty-eight pages withheld in full) and miscellaneous records (seven pages released in part) pertaining to animal cages; and III) Institutional Animal Care and Use Committee (IACUC) Records (fifty-six pages released in part), Internal Huntingdon Memoranda (seven pages released in part and thirty-three pages withheld in full), and Internal USDA Investigatory Memoranda (twenty-seven pages released in part). (See Declaration of Lesia M. Banks, Assistant Director, Freedom of Information Staff, Legislative and Public Affairs Division, Animal and Plant Health Inspection Service, USDA [hereinafter Banks Decl.] ¶¶ 3-6, filed herewith.) Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 4 of 42 -3- 3. In sum, 503 pages were withheld in full and 514 pages were withheld in part, pursuant to Exemption 4 of the Freedom of Information Act, 5 U.S.C. § 552 (b)(4), (2000 & West Supp. II 2002), for a total of 1017 pages at issue. (See Banks Decl. ¶¶ 3-6.) 4. The records at issue were created by Huntingdon Life Sciences (Huntingdon), a wholly-owned subsidiary of intervenor- defendant Life Science Research, Inc. as part of its business of product testing conducted on behalf of the pharmaceutical, biotechnology, medical, and chemical companies that are its clients. (See First Gilmore Decl. ¶ 5.) 5. Defendant obtained these records when it conducted an investigation of Huntingdon for alleged violations of the Animal Welfare Act (AWA), 7 U.S.C. §§ 2131-59. (See id. ¶ 4.) 6. Defendant protected records described as "Final Test Reports and Related Records" that consist of 124 pages withheld in full; these records provide detailed descriptions of the designs and methods used in Huntingdon's studies, including the "stability of the experimental compound under the conditions of administration," descriptions of "all circumstances that may have affected the quality or integrity of the data generated by the test," statistical methods for analyzing the data, descriptions of dosages and descriptions of the experimental compounds, as well as Huntingdon's summaries of the data. (Banks Decl. ¶ 4A.) Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 5 of 42 -4- In addition, defendant protected information in this category that reveals the procedures used for administering the experimental compounds, the configuration of Huntingdon's facilities, the type and design of Huntingdon's equipment, the physiological and health effects of the experimental compounds being tested, the pharmacological responses of test subjects, and Huntingdon's data collection methods, including its unique computerized statistical methods employed in analyzing data. (See First Gilmore Decl. ¶¶ 15-16; see also Caulfield Decl. ¶¶ 35, 40- 41.) For a document-by-document description of the records at issue, see Bates Stamps LSR0029-LSR1974 as delineated on the second Vaughn Index, filed herewith. (See Banks Decl. ¶ 4A.) 7. Defendant protected records described as "Clinical Observation Raw Data Reports" that consist of 121 pages withheld in full that contain "no information other than raw data" from the tests conducted by Huntingdon. (Id. ¶ 5A.) For a document- by-document description of the records at issue, see Bates Stamps LSR1294-LSR2126 as delineated on the second Vaughn Index. (See id.) 8. Defendant protected records described as "Interim Tests Reports" that consist of twenty-two pages withheld in full and contain "summaries of clinical observation taken during the tests" and include details such as urinalysis, blood pressure, hematology, clinical chemistry, and food and fluid intake. (Id. Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 6 of 42 -5- ¶ 5B.) For a document-by-document description of the records at issue, see Bates Stamps LSR1706-LSR1910 as delineated on the second Vaughn Index. (See id.) 9. Defendant protected records described as "Necropsy and Postmortem Examination Reports" that consist of twenty-three pages that were withheld in full and that contain observations that were taken during examinations of the bodies of dead animals. (See id. ¶ 5C.) These records describe the "physiological and health effects of proprietary experimental compounds" on the test subjects, including information on "specific dosages administered to test subjects," the type of equipment used in the collection of the data, "the sequence and timing of events, the number of staff assigned to certain tasks, and the time required for task completion." (id.; see also Caulfield Decl. ¶ 36.) For a document-by-document description of the records at issue, see Bates Stamps LSR1313-LSR2130 as delineated on the second Vaughn Index. (See Banks Decl. ¶ 5C.) 10. Defendant protected records described as "Viability Records" that consist of 397 pages released in part and fifty- eight pages withheld in full. (See Banks Decl. ¶ 5D.) These records are "charts on which clinical observations of the condition of test subjects taken during testing are recorded" and contain detailed environmental conditions, specifics about the research area, and quantitative information about productivity Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 7 of 42 -6- and efficiency at Huntingdon. (Id.; see also Caulfield Decl. ¶ 37.) For a document-by-document description of the records at issue, see Bates Stamps LSR0142-LSR2373 for those pages released in part and Bates Stamps LSR0317-LSR1100 for those pages withheld in full as delineated on the second Vaughn Index. (See Banks Decl. ¶ 5D.) 11. Defendant protected, pursuant to Exemption 4, records described as "Veterinary Treatment Requests and Logs," consisting of twenty pages released in part and ninety-four pages withheld in full. (See id. ¶ 5E.) These records contain descriptions of "treatments requested for and provided to the test subjects" related to treatments provided to "alleviate reactions of side effects caused by the tested compounds." (Id.) Those parts of the records related to treatments that address conditions not linked to the tests were released. (See id.; see also First Gilmore Decl. ¶ 16.) For a document-by-document description of the records at issue, see Bates Stamps LSR0140-LSR2376 for those pages released in part and Bates Stamps LSR0226-LSR2381 for those pages withheld in full as delineated on the second Vaughn Index. (See Banks Decl. ¶ 5E.) Also included in this group are observation sheets that consist of twenty-eight pages withheld in full that "relate to physical observation of animals in the studies [as] required by the Standard Operating procedures for the particular study." (Id. ¶ 5H.) For a document-by-document Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 8 of 42 -7- description of the records at issue, see Bates Stamps LSR0313- LSR2165 as delineated on the second Vaughn index. (See id.) Additionally, this group includes seven pages released in part that consist of miscellaneous records that contain "study number and amounts projected and spent by Huntingdon on primate cages." (Id. ¶ 6.) For a document-by-document description of the records at issue, see Bates Stamps LSR0228-LSR0472 as delineated on the second Vaughn index. (See id.) 12. Defendant protected records described as IACUC records that consist of fifty-six pages released in part. (See id. ¶ 4B.) The pages contain notes from IACUC meetings, memoranda related to the discussions occurring during these meetings, and inspection reports that were discussed at the meetings. (See id.) The issues discussed in these records include detailed descriptions of Huntingdon's research facilities and equipment, information technology systems, employee training programs, and implementation of testing procedures. (See id.) For a document- by-document description of the records at issue, see Bates Stamps LSR2102-LSR2231 as delineated on the second Vaughn Index. (See id.) 13. Defendant protected records described as "Internal Huntingdon Memoranda" that consist of seven pages released in part and thirty-three pages withheld in full. (See id. ¶ 5F.) These records consist of Huntingdon's "discussions of issues that Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 9 of 42 -8- arose during the course of tests," and concern the use of test designs and methods in light of observations taken during the tests. (Id.) For a document-by-document description of the records at issue, see Bates Stamps LSR0139-LSR2062 as delineated on the second Vaughn Index. (See id.) 14. Defendant protected records described as "Internal USDA Investigatory Memoranda" that consist of twenty-seven pages released in part and contain discussions of the "bases for each charge that USDA contemplated bringing against Huntingdon for violations of the Animal Welfare Act." (See id. ¶ 5G.) For a document-by-document description of the records at issue, see Bates Stamps LSR0001-2272 as delineated on the second Vaughn Index. (See id.) 15. Defendant has reviewed each page of the responsive records and has released all reasonably segregable, nonexempt information to plaintiff. Defendant considered carefully the pages it withheld in full to determine if any portions could be segregated and released. (See First Gilmore Decl. ¶¶ 16-18; Banks Decl. ¶¶ 4B, 5D, 5E.) Defendant has determined that it is not possible to segregate any information from those pages Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 10 of 42 -9- without disclosing information that is protected under Exemption 4. Respectfully submitted, KENNETH L. WAINSTEIN (D.C. Bar #451058) United States Attorney R. CRAIG LAWRENCE (D.C. Bar #171538) Assistant United States Attorney Dated: August 3, 2005 ANNE D. WORK (D.C. Bar #376314) Attorney-Advisor Office of Information and Privacy United States Department of Justice Flag Building, Suite 570 Washington, DC 20530-0001 (202) 616-5494 Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 11 of 42 1 See intervenor-defendant's Memorandum of Points and Authorities in Support of Unopposed Motion for Leave to Intervene, filed June 13, 2002, at 1. UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA IN DEFENSE OF ANIMALS, ) ) Plaintiff, ) ) v. ) ) THE UNITED STATES DEPARTMENT ) OF AGRICULTURE, ) ) Civil Action No. 02-0557 (RWR) Defendant, ) ) and ) ) LIFE SCIENCES RESEARCH, INC., ) ) Intervenor-Defendant. ) ) MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF DEFENDANT'S RENEWED MOTION FOR SUMMARY JUDGMENT Preliminary Statement Plaintiff commenced this action under the Freedom of Information Act (FOIA), 5 U.S.C. § 552 (2000 & West Supp. II 2002), seeking access to records concerning an investigation by defendant United States Department of Agriculture (USDA) of Huntingdon Life Sciences (Huntingdon), a wholly-owned subsidiary of intervenor-defendant Life Sciences Research, Inc.,1 for alleged violations of the Animal Welfare Act (AWA), 7 U.S.C. §§ 2131-59 (2000). In support of its renewed motion for summary judgment, defendant has filed herewith the Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 12 of 42 -2- 2 The first and second declarations of Hugh Gilmore [hereinafter First Gilmore Decl. and Second Gilmore Decl.] filed December 12, 2002, and March 21, 2003, respectively; the Declaration of Michael Caulfield, [hereinafter Caulfield Decl.], General Manager of Huntingdon, filed March 21, 2003; and the Declaration of Francis Keyser, Investigator, Investigations and Enforcement Services Division of the Animal and Plant Health Inspection Service, USDA, filed March 21, 2003, provide a full chronology of the administrative processing of the records requested by plaintiff and contain an explanation and justification for defendant's prior invocation of Exemption 4 of the FOIA, 5 U.S.C. § 552(b)(4). The Banks Declaration further sets forth defendant's bases for invoking Exemption 4. Declaration of Lesia M. Banks, Assistant Director, Freedom of Information Staff, Legislative and Public Affairs Division, Animal and Plant Health Inspection Service, USDA [hereinafter Banks Decl.], which explains further the bases upon which the remaining records at issue were withheld. Based upon the accompanying Banks Declaration, the entire record herein, and for the reasons set forth below, defendant USDA respectfully submits that there exists no genuine issue of material fact and that it is entitled to judgment as a matter of law pursuant to Rule 56 of the Federal Rules of Civil Procedure. Factual and Procedural Background By letter dated November 20, 2000, plaintiff submitted a FOIA request to defendant USDA seeking access to records concerning its investigation of Huntingdon for alleged violations of the AWA.2 (See First Gilmore Decl. ¶ 8.) Plaintiff commenced this action on March 22, 2002. (See id. ¶ 10.) On December 12, 2002, defendant filed a motion for Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 13 of 42 -3- 3 This second Vaughn Index was not filed with the Court initially; rather, a copy was provided to plaintiff on December 22, 2004, by electronic mail. In addition, a paper copy was mailed on the same day. A copy of this second Vaughn Index is being filed with the Court herewith. 4 The parties filed joint status reports on February 11, March 11 [hereinafter Second Joint Status Rep.], April 30 [hereinafter Third Joint Status Rep.], May 13, and June 15, 2005 [hereinafter Fifth Joint Status Rep.]. summary judgment; plaintiff thereafter filed a cross-motion for summary judgment; and by Order dated September 28, 2004, this Court found that defendant had conducted an adequate search, but "failed to provide a specific index with which to judge the validity" of the claimed exemptions, thereby providing "insufficient evidence" for the Court to conduct a "segregability analysis"; thus, the Court ordered defendant to produce a supplemental Vaughn Index. (Mem. Op. & Order, filed September 28, 2004, at 2, 32-34.) In addition, the Court ordered the parties to confer and submit a joint status report. (See id. at 34.) In accordance with that Order, the parties filed a joint status report on October 28, 2004, in which defendant agreed to provide plaintiff with a second Vaughn Index by December 22, 2004. Defendant provided plaintiff with such an index on December 22, 2004.3 Thereafter, the parties filed a series of five joint status reports in 2005.4 In these reports, the parties agreed that records containing the following were no Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 14 of 42 -4- longer at issue: information withheld pursuant to Exemptions 5, 6, and 7(C) of the FOIA, 5 U.S.C. § 552(b)(5), (6), (7)(C); information concerning "standard operation procedures"; information concerning test protocols and protocol amendments; information identifying Huntingdon's clients and customers; and information identifying the formulas, compounds, or products that were the subject of Huntingdon's research projects. (See Second Joint Status Rep. at 2; Third Joint Status Rep. at 2; Fifth Joint Status Rep. at 1-2.) Furthermore, as confirmed by this Court, the parties had agreed earlier that the following areas were not in dispute: trade secret protection under Exemption 4 of the FOIA, 5 U.S.C. § 552 (b)(4), for drug products, drug compounds, and test protocols and protocol amendments. (See Mem. Op. & Order at 28.) In addition, plaintiff did not dispute that the information withheld under Exemption 4 was "commercial" and "obtained from a person." (Id.) Therefore, only defendant's invocation of the "confidential" element of Exemption 4 for the following three categories of records remains at issue in this case: I) Final Test Reports and Related Records (124 pages withheld in full), Clinical Observation Raw Data Reports (121 pages withheld in full), and Interim Test Reports (twenty-two pages withheld in full); Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 15 of 42 -5- II) Necropsy and Postmortem Examination Reports (twenty-three pages withheld in full), Viability Records (397 pages released in part and fifty-eight pages withheld in full), Veterinary Treatment Request and Logs (twenty pages released in part and ninety-four pages withheld in full), including, in addition, observation sheets (twenty-eight pages withheld in full) and miscellaneous records pertaining to animal cages (seven pages released in part); and III) Institutional Animal Care and Use Committee (IACUC) Records (fifty-six pages released in part), Internal Huntingdon Memoranda (seven pages released in part and thirty-three pages withheld in full), and Internal USDA Investigatory Memoranda (twenty-seven pages released in part). (See Banks Decl. ¶¶ 4- 6.) Of these records, 503 pages were withheld in full and 514 pages were released in part, for a total of 1017 pages at issue. Defendant hereby renews its motion for summary judgment for these records on the ground that the information was properly withheld pursuant to Exemption 4. For the reasons set forth below, defendant respectfully suggests that there exists no genuine issue of material fact and that it is entitled to judgment as a matter of law pursuant to Rule 56 of the Federal Rules of Civil Procedure. Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 16 of 42 -6- Argument Defendant Has Properly Withheld Confidential Commercial Information Pursuant To Exemption 4 Exemption 4 of the FOIA protects from disclosure "commercial or financial information obtained from a person [that is] privileged or confidential." 5 U.S.C. § 552(b)(4). As established above, plaintiff does not dispute that the information at issue is "commercial" and "obtained from a person." (Mem. Op. & Order at 28.) Thus, the only remaining issue is whether the information is "confidential." As is demonstrated below, the information withheld under Exemption 4 readily satisfies the "confidential" requirement because its disclosure would likely cause Huntingdon substantial competitive harm. The D.C. Circuit has held that information is "confidential" under Exemption 4 if its release is likely to cause substantial harm to the competitive position of the person from whom it was obtained. See, e.g., National Parks & Conservation Ass'n v. Morton, 498 F.2d 765, 770 & n.17 (D.C. Cir. 1974). It is not disputed that the information at issue in this case was submitted involuntarily to defendant USDA pursuant to its investigation of Huntingdon under the AWA. (See First Gilmore Decl. ¶ 5.) Accord 9 C.F.R. § 2.38(a)-(b) (2002) (USDA regulations requiring research facilities to make available to USDA investigators for examination and copying any information Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 17 of 42 -7- concerning the business of the research facility, and to allow USDA investigators to examine records required to be kept by the AWA and its implementing regulations). Therefore, the less stringent Exemption 4 standard for withholding information that is "voluntarily" submitted to the Government is inapplicable and the competitive harm test is the proper standard in this case. See Critical Mass Energy Project v. NRC, 975 F.2d 871, 879 (D.C. Cir. 1992) (en banc). A showing of actual competitive harm is not required, nor is "a sophisticated economic analysis of the likely effects of disclosure" required. Pub. Citizen Health Research Group v. FDA, 704 F.2d 1289, 1291 (D.C. Cir. 1983). Rather, as the Court has already recognized in this case, a showing of actual competition and a likelihood of substantial competitive injury to the submitter will suffice. See Mem. Op. & Order at 29; accord Gulf & W. Indus. v. United States, 615 F.2d 527, 530 (D.C. Cir. 1979). In the present case, Huntingdon is a Contract Research Organization (CRO) that sells scientific research and development services to its clients, pharmaceutical, biotechnology, medical device, and chemical companies and, as such, faces actual competition from over 1200 other USDA- registered research facilities. (See First Gilmore Decl. ¶¶ 15- 17; see also Caulfield Decl. ¶¶ 8, 12-31, 35-43.) The Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 18 of 42 -8- pharmaceutical industry is known to be "a highly competitive market where companies routinely attempt to discover a possible advantage over their competitors." Pub. Citizen Health Research Group v. NIH, 209 F. Supp. 2d 37, 47 (D.D.C. 2002.) Indeed, Mr. Caulfield uses the word "fierce" to describe the competition among the twenty large, global-reaching research organizations such as Huntingdon. (Caulfield Decl. ¶ 8.) Huntingdon designs its own tests and develops its own testing methods and uses these in conducting research on proprietary experimental compounds; it sells the results of its efforts to its clients. (See First Gilmore Decl. ¶ 3.) Huntingdon's clients are charged hundreds of thousands of dollars for these research and development services. (See id. ¶ 5.) "Extensive use of CROs by companies in the pharmaceutical, biotechnology, medical device, and chemicals industries has become standard practice." (Caulfield Decl. ¶ 6.) As Mr. Gilmore attests, not only does Huntingdon face competition, its clients, those companies relying on CROs, also face serious competitors. (See First Gilmore Decl. ¶ 18.) It is well known that developing new drugs is highly competitive and that the companies routinely attempt to discover any advantage over competitors. See Pub. Citizen, 209 F. Supp. at 47. Mr. Caulfield attests that developing a new medicine can Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 19 of 42 -9- take over ten years and hundreds of millions of dollars and that "competing companies are working on similar compounds intended to treat the same medical condition in a race to the finish line." (Caulfield Decl. ¶ 32.) Mr. Caulfield further attests that "competition to find new and better cures for disease" requires that Huntingdon and its clients maintain "strict confidentiality" in order to protect Huntingdon's extensive testing and development process. (Id. ¶¶ 32, 33.) Release of information about proprietary experimental tests could cause harm to Huntingdon's clients by allowing competitors of those clients a head start in developing competitive products because the competitors would be able to focus their own research and development effort on those compounds that have promise. (See id.) Mr. Caulfield attests that the first company to market a new drug often reaps a substantial advantage because the time required to test a new drug is a key factor in a company's financial success. (See id.) I. Information that reveals testing, including Huntingdon's Final Test Reports and Related Records, Clinical Observation Raw Data Reports, and Interim Test Reports In this case, defendant USDA has withheld information concerning Huntingdon's tests of proprietary experimental Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 20 of 42 -10- 5 Plaintiff does not dispute that the compounds or drug products being tested are trade secrets and, as such, are not at issue. (See Mem. Op. & Order at 28). compounds. (See Banks Decl. ¶ 3; First Gilmore Decl. ¶ 16; see also Caulfield Decl. ¶¶ 35, 40-41.)5 Ms. Banks describes the first of the three groups in this category, "Final Test Reports and Related Records," as consisting of 124 pages withheld in full that contain detailed descriptions of the designs and methods used in Huntingdon's studies, including the "stability of the experimental compound under the conditions of administration," descriptions of "all circumstances that may have affected the quality or integrity of the data generated by the test," statistical methods for analyzing the data, descriptions of the dosages and descriptions of the experimental compounds, as well as Huntingdon's summaries of the data. (Banks Decl. ¶ 4A.) In addition, this category contains information that reveals the procedures used for administering the experimental compounds, the configuration of Huntingdon's facilities, and the type and design of the equipment. (See First Gilmore Decl. ¶ 15.) As such, this information reveals the physiological and health effects of the experimental compounds being tested, the pharmacological responses of test subjects, and Huntingdon's data collection methods, including its unique computerized statistical methods Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 21 of 42 -11- 6 For a document-by-document description of the records at issue in this group, see Bates Stamps LSR0029-LSR1974 delineated on the second Vaughn Index. (See Banks Decl. ¶ 4A.) 7 For a document-by-document description of the records at issue in this group, see Bates Stamps LSR1294-2126 as delineated on the second Vaughn Index. (See id.) 8 For a document-by-document description of the records at issue in this group, see Bates Stamps LSR1706-1910 as delineated on the second Vaughn Index. (See id.) employed in analyzing data. (See id. ¶ 16; see also Caulfield Decl. ¶¶ 35, 40-41.)6 Ms. Banks attests that the records described in the second group of this category, "Clinical Observation Raw Data Reports," consist of 121 pages withheld in full that contain "no information other than raw data" from the tests conducted by Huntingdon. (Banks Decl. ¶ 5A.)7 The records in the third group in this category, "Interim Tests Reports," consist of twenty-two pages withheld in full and contain "summaries of clinical observation taken during the tests" and include details such as urinalysis, blood pressure, hematology, clinical chemistry, and food and fluid intake. (Id. ¶ 5B.)8 A) Competitive Harm Courts have long recognized that substantial competitive harm can be caused by release of information such as that contained in Category I. For example, the results of the tests of proprietary experimental compounds themselves have been Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 22 of 42 -12- protected. See Pub. Citizen, 997 F. Supp. at 65-66 (concluding that the release of records "contain[ing] the results of clinical studies . . . that disclose clinical observations of [test subjects] and related information" likely would cause substantial competitive harm); Citizens' Comm'n on Human Rights v. FDA, No. 92-CV-5313, 1993 WL 1610471, at **9-10 (C.D. Cal. 1993) (holding that raw research data generated during testing of developmental drug were properly withheld under Exemption 4), aff'd in pertinent part, 43 F.3d 1325 (9th Cir. 1995); see also Heeney v. FDA, 7 Fed. Appx. 770 (9th Cir. 2001) (concluding that information concerning product testing "falls squarely within the exemption provided by § 552(b)(4)"). Furthermore, as recognized by the D.C. Circuit, substantial competitive harm can be caused by the release of product research test results because it would allow competitors to benefit from that data "without incurring the time, labor, risk, and expense involved in developing them independently". Webb v. HHS, 696 F.2d 101, 103 (D.C. Cir. 1982); see Pub. Citizen v. FDA, 539 F. Supp. 1320, 1327 (D.D.C. 1982) (recognizing that the release of product test data would cause "substantial competitive injury" because "competitors would be receiving, free of charge, the benefits of this costly research and testing"), aff'd in pertinent part, 704 F.2d 1280 (D.C. Cir. 1983). Thus, it is clear that allowing competitors access to Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 23 of 42 -13- information that they would otherwise have to spend considerable funds to develop on their own would be an unfair advantage, causing competitive harm to Huntingdon and its clients. The Supreme Court recognized this competitive harm in a non-FOIA context in which competitors attempted to use research data to develop competing products that could be "marketed at relatively low prices" because they would be produced without "the research, development, and promotional costs normally associated with the creation and marketing of an original product." United States v. Generix Drug Corp., 460 U.S. 453, 455 n.1 (1983); see also Tri-Bio Labs., Inc. v. United States, 836 F.2d 135, 143 (3d Cir. 1987) (noting that a "'me-too' manufacturer seeks to enjoy, without remunerating the pioneer manufacturer, the benefit of the pioneer's substantial investment in research and testing"). Thus, it is well established that release of this type of information could likely cause Huntingdon substantial competitive harm because it would allow competitors to gain "valuable insight" into Huntingdon's data and would provide competitors with "fundamental and critical business intelligence," allowing the competitors to "replicate Huntingdon's procedures" without investing the time, effort, or money that Huntingdon expended in the development of its tests. (See Caulfield Decl. ¶¶ 35, 40-41; see also First Gilmore Decl. Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 24 of 42 -14- ¶ 18.) In fact, Ms. Banks calls these records "blueprints" for Huntingdon's research services. (See Banks Decl. ¶ 7.) Furthermore, as stated by Mr. Gilmore, release of the test results would also reveal the proprietary designs and methods used to generate, collect, and analyze that data, allowing competing businesses to market their services at a lower price, thus eroding Huntingdon's market share. (See First Gilmore Decl. ¶ 18; see also Banks Decl. ¶ 7.) Moreover, release of the test results, whether in final, interim, or "raw" data form, would cause substantial competitive harm not just to Huntingdon, but to Huntingdon's clients. These test results are an important preliminary step in assessing the performance of proprietary experimental compounds, and as such, the withheld records contain detailed observations about various aspects of the performance of the experimental compounds that Huntingdon tested on behalf of its clients. (See Banks Decl. ¶ 8B.) Given that such testing is done for the purpose of product development, competitors could appropriate these test results to accelerate the production of their own competing products without incurring the substantial research and development costs required to do so. (See id.) As discussed above, courts have long recognized the substantial competitive harm that would be caused by an unfair appropriation of costly product research and development data. Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 25 of 42 -15- See, e.g., Pub. Citizen, 997 F. Supp. at 63-64 (noting that the release of product research test results "would direct competitors as to which paths to take based on [the submitter's] reported successes and failures," which would enable them to save substantial research and development costs and to bring their competitive products to market sooner); Pub. Citizen, 539 F. Supp. at 1327 (recognizing that the release of product test data would cause "substantial competitive injury" because "competitors would be receiving, free of charge, the benefits of this costly research and testing"). Indeed, as the D.C. Circuit observed: Because competition in business turns on the relative costs and opportunities faced by members of the same industry, there is a potential windfall for competitors to whom valuable information is released under FOIA. If those competitors are charged only minimal FOIA retrieval costs for the information, rather than the considerable costs of private reproduction, they may be getting quite a bargain. Such bargains could easily have competitive consequences not contemplated as part of FOIA's principal aim of promoting openness in government. Worthington Compressors, Inc. v. Costle, 662 F.2d 45, 51 (D.C. Cir. 1981). B) Segregation Under the FOIA statute, all reasonable, segregable, nonexempt information must be disclosed. See 5 U.S.C. § 552(b) (sentence immediately following exemptions). In fact, the standard in the D.C. Circuit for segregating material is well established: an agency cannot justify withholding an entire Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 26 of 42 -16- page simply because it contains some exempt material. See Schiller v. NLRB, 964 F.2d 1205, 1209 (D.C. Cir. 1992) (explaining that since 1974, "the segregability requirement has been the law of the land"); Mead Data Cent., Inc. v. United States Dept' of the Air Force, 566 F.2d 242, 260 (D.C. Cir. 1977) (stating that an agency cannot justify withholding an entire document just because it contains some exempt material). Mindful of this standard, defendant conducted a line-by- line review of each record in the category and considered carefully the pages it withheld in full concerning Huntingdon's testing and determined that this information, in addition to revealing the tests themselves, would reveal Huntingdon's costs and profits margins, its facilities, equipment, information technology systems, and the expertise of the employees who perform the work, as well as Huntingdon's confidential methods and procedures used in the test. (See First Gilmore Decl. ¶ 17.) Mr. Gilmore attests that release of this information would result in substantial competitive harm by allowing competitors to "appropriate those procedures and methods to develop their own competing research services." (Id. ¶ 18.) In addition, the test results include information such as statistical methods employed for analyzing the data; conclusions drawn from the analysis; and details on dosages, including descriptions of the dosing regimen, the route of administrating Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 27 of 42 -17- the various dosages, and the stability of the dosages of the proprietary experimental compounds. (See Banks Decl. ¶ 4.) Thus, Ms. Banks attests that these records contain no reasonably segregable nonexempt information. (See id. ¶¶ 4A, 5A, 5B.) The interim test reports are mid-study status reports containing clinical observations of the various animals. (See id. ¶ 5B.) These reports include details such as blood pressure, "fecal and fluid output, food and fluid intake, body weight of the animals," and hematology. (Id.) These clinical observations and recordings characterize the "physiological and health effects of the proprietary experimental compounds tested by Huntingdon," and after a careful review, Ms. Banks attests that these interim reports contain no reasonably segregable nonexempt information. (Id.) The raw data reports, containing only data that has not been analyzed or summarized, were withheld in full after a thorough review. (See id. ¶ 5A.) Mr. Caulfield attests that this raw data "would be of great value to its [Huntingdon's] competitors, in that it would allow them to easily derive important competitive information" and to benefit from Huntingdon's efforts. (Caulfield Decl. ¶ 35.) Therefore, defendant USDA respectfully suggests that the results of the tests, including clinical observation raw data reports, interim reports, and final test reports, that Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 28 of 42 -18- Huntingdon conducted on behalf of its clients, were properly withheld under Exemption 4. II. Information that reveals Huntingdon's Necropsy and Postmortem Examination Reports, Viability Records, and Veterinary Treatment Requests and Logs The second category of records at issue concern information that would reveal animal species, pharmacological responses of test subjects, detailed environmental conditions, specifics about the research area in the which studies were conducted, and procedures employed in providing veterinary care and treatment to subjects. (See Caulfield Decl. ¶¶ 36-38.) The first group of records in this category, "Necropsy and Postmortem Examination Reports," consist of twenty-three pages withheld in full and contain observations that were taken during examinations of the bodies of dead animals. (See Banks Decl. ¶ 5C.) These records describe the "physiological and health effects of proprietary experimental compounds" on the test subjects. (Id.) Mr. Caulfield attests that these records "contain information on specific dosages administered to test subjects," the type of equipment used in the collection of the data, "the sequence and timing of events, the number of staff assigned to certain tasks, and the time required for task completion." (Caulfield Decl. ¶ 36.) Further, the records Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 29 of 42 -19- 9 For a document-by-document description of the records at issue in this group, see Bates Stamps LSR1313-LSR2130 as delineated on the second Vaughn Index. (See Banks Decl. ¶ 5C.) 10 For a document-by-document description of the records at issue in this group, see Bates Stamps LSR0313-LSR2165 as delineated on the second Vaughn index. (See id.) 11 For a document-by-document description of the records at issue in this group, see Bates Stamps LSR0228-LSR0472 as delineated on the second Vaughn index. (See id.) identify by name the specific procedure or activity involved and detail the specifications for collecting data. (See id.)9 Also included in this group are observation sheets that consist of twenty-eight pages withheld in full that "relate to physical observation of animals in the studies [as] required by the Standard Operating [P]rocedures for the particular study." (Id. ¶ 5H.)10 Additionally, this group includes seven pages released in part that consists of miscellaneous records that contain "study number and amounts projected and spent by Huntingdon on primate cages," revealing Huntingdon's equipment and configuration of its work area. (Id. ¶ 6; see also Caulfield Decl. ¶¶ 36-38.)11 The records in the second group in this category, "Viability Records," consist of 397 pages released in part and fifty-eight pages withheld in full. (See Banks Decl. ¶ 5D.) Ms. Banks attests that these records are "charts on which clinical observations of the condition of test subjects taken during testing are recorded." (Id.) Mr. Caulfield attests that Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 30 of 42 -20- 12 For a document-by-document description of records in at issue this group, see Bates Stamps LSR0142-LSR2372 for those pages released in part and LSR0317-1100 for those pages withheld in full as delineated on the second Vaughn Index. (See Banks Decl. ¶ 5D.) 13 For a document-by-document description of the records at issue in this group, see Bates Stamps LSR 0140-2376 for those pages released in part and LSR0223-2381 for those pages withheld in full as delineated on the second Vaughn Index. (See id.) viability records also contain "detailed environmental conditions and specifics about the research area" and that they contain quantitative information about productivity and efficiency at Huntingdon. (Caulfield Decl. ¶ 37.)12 The records in the third group in the category, "Veterinary Treatment Requests and Logs," consist of twenty pages released in part and ninety-four pages withheld in full and contain descriptions of "treatments requested for and provided to the test subjects." (Id. ¶ 5E.) Most of the records contain information related to treatments provided to "alleviate reactions of side effects caused by the tested compounds." (Id.) Those portions of the records that contain information related to treatments that address conditions not linked to the tests were released. (See id.; see also First Gilmore Decl. ¶ 16.)13 A) Competitive Harm As with the Category I records, release of the withheld information in Category II would allow competitors of Huntingdon Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 31 of 42 -21- to benefit from the time and effort it has expended on compound testing, to the corresponding detriment of Huntingdon. Courts have long recognized that release of confidential reports and records such as the postmortem examination reports and viability records that comprise a portion of the records located within Category II can result in competitive harm, explaining that eliminating the time and effort required to bring a product to market is but one of the numerous types of competitive injury recognized by Exemption 4. See SMS Data Prods. Group, Inc. v. United States Dep't of the Air Force, No. 88-0481, 1989 WL 201031, at *3 (D.D.C. Mar. 31, 1989) (stating that allowing competitors to have access to information that "they would have had to spend considerable funds to develop on their own" results in competitive harm). Information concerning pharmacological responses, for example, would reveal the results of and responses from particular dosages of specific proprietary experimental compounds, showing the benefits or side effects of each dosage of the compounds, thus helping competitors to advance their research through use of this information. (See First Gilmore Decl. ¶ 17.) The courts have recognized that release of such information "would direct competitors as to which paths to take" based on the reported success and failures. Pub. Citizen, 997 F. Supp. at 63-64. This in turn would enable the competitors to save substantial research and development Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 32 of 42 -22- costs and bring their competitive products to the market sooner by allowing competitors to receive "free of charge, the benefits of this costly research and testing." Pub. Citizen, 539 F. Supp. at 1327. Courts have approved the withholding of this type of information because "it would be costly for competitors to figure out [this data] through their own efforts." Pub. Citizen Health Research Group v. FDA, No. 99-0177, 2000 U.S. Dist. LEXIS 4108, at **11-12 (D.D.C. Jan. 19, 2000.) Further, those portions containing detailed descriptions of symptoms resulting from the administration of the tested compounds and the treatment provided to alleviate those symptoms were withheld because these details would be of great value to competitors. (See Caulfield Decl. ¶ 36.) Mr. Caulfield attests that a competitor could use these detailed description of symptoms to under-price their services in pivotal "head-to-head competition with Huntingdon for awards of individual studies or programs" by easily deriving information, by replicating Huntingdon's procedures, or by copying the details, all without expending the time, effort, or money that Huntingdon has expended on development and testing. (Id.; see also First Gilmore Decl. ¶ 16.) Similarly, the veterinary treatment records identify by name the specific procedures and provide details such as the specifics of sequence and timing of treatments and the number of Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 33 of 42 -23- staff members assigned to certain tasks. (See Caulfield Dec. ¶ 37.) Further, the records distinguish between veterinary care for reactions to the proprietary experimental compounds and ordinary veterinary care, permitting competitors to use this information to "measure and improve their own productivity" by replicating Huntingdon efforts, thereby benefitting from work done by Huntingdon without exerting similar efforts of their own. (See id.; see also Banks Decl. ¶ 5E.) B) Segregation For this second category, as in the first category, defendant conducted a line-by-line review of each record in order to segregate all nonexempt information. (See Banks Decl. ¶¶ 5C, 5E; First Gilmore Decl. ¶ 16.) In fact, Ms. Banks attests specifically that only those portions of veterinary treatment request and logs containing confidential business information were excised and the "remaining portions of these records were released because they describe symptoms and treatments that do not reveal anything about the physiological and health effects of proprietary experimental compounds." (See Banks Decl. ¶ 5E; see also First Gilmore Decl. ¶ 16.) Also, defendant was able to segregate and release portions of 397 pages of viability records. (See First Gilmore Decl. ¶ 16.) Mr. Gilmore states that defendant released observations Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 34 of 42 -24- that did not reveal anything about test results; for example, reports about subject animals being bitten by other subject animals or being injured by getting caught in their own cages were released. (See id.) Regarding the fifty-eight pages of viability records withheld in full, Mr. Gilmore attests that these records are "charts [with] numerous preprinted columns for recording anticipated side effects specific to the test compounds themselves. Thus, the very structure of these charts reveals the anticipated results of the tests in which they were used." (Id.) These records were withheld in full because "nothing of informational value would have remained on these charts after the excision of the clinical observations and the columns that reveal the anticipated results of the tests." (Id.) Ms. Banks attests that the twenty-three pages of necropsy and postmortem examination reports "contain no reasonably segregable nonexempt information. (See Banks Decl. ¶ 5C.) Mr. Caulfield declared that these records were withheld because the details in them "closely mirror the specifics contained in the Huntingdon SOPs" (Standard Operating Procedures), and would provide Huntingdon's competitors with a "comprehensive profile" of Huntingdon's procedures. (Caulfield Decl. ¶ 36.) Therefore, defendant USDA respectfully suggests that the necropsy and postmortem examination reports, viability records, Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 35 of 42 -25- and veterinary treatment requests and logs were properly withheld under Exemption 4 and that all meaningful, nonexempt information was segregated and released. III. Information from Institutional Animal Care And Use Committee (IACUC) Records, Internal Huntingdon Memoranda, and Internal USDA Investigatory Memoranda The third category of records at issue concern numerous references to Huntingdon's "development of study designs and methods," to program reviews including discussions of "facility inspection reports," and to evaluations of its "unique training programs." (Caulfield Decl. ¶¶ 42-43.) The first group of records in this category, IACUC records, consists of fifty-six pages released in part and contains information from IACUC meetings. (See Banks Decl. ¶ 4B.) The pages contain notes from IACUC meetings, memoranda related to the discussions occurring during those meetings, and inspection reports that were discussed at the meetings. (See id.) The issues discussed in these records include detailed descriptions of Huntingdon's research facilities and equipment, its information technology systems, its employee training programs, and its implementation of testing procedures. (See id.) Mr. Caulfield attests that these records contain numerous details about Huntington's facility configuration and "specific details Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 36 of 42 -26- 14 For a document-by-document description of the records in this group, see LSR2102-2231 as delineated on the second Vaughn Index. (See Banks Decl. ¶ 4B.) 15 For a document-by-document description of the records at issue in this group, see Bates Stamps LSR0139-2062 as delineated on the second Vaughn Index. (See id.) 16 For a document-by-document description of records at issue in this group, see Bates Stamps LSR0001-2272 as delineated on the second Vaughn Index. (See id.) about confidential research programs placed at Huntingdon by its clients." (Caulfield Decl. ¶ 43.)14 The records in the second group in this category, "Internal Huntingdon Memoranda," consist of seven pages released in part and thirty-three pages withheld in full. (See id. ¶ 5F.) Ms. Banks attests that these records consist of Huntingdon's "discussions of issues that arose during the course of tests," and concern the use of test designs and methods in light of observations taken during the tests. (Id.)15 The records in the third group in this category, "Internal USDA Investigatory Memoranda," consist of twenty-seven pages released in part and contain discussions of the "bases for each charge that USDA contemplated bringing against Huntingdon for violations of the Animal Welfare Act." (Id. ¶ 5G.)16 A) Competitive Harm As with the first two categories, release of the proprietary information in category three would cause harm in that this information could be used by competitors to duplicate Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 37 of 42 -27- Huntingdon's efforts; for example, competitors could copy "Huntingdon's unique training programs" or its technology systems and thus reduce their business expenses and thereby obtain an "unfair business advantage." (Caulfield Decl. ¶ 43.) It is well established that Exemption 4 protects information such as data describing a company's workforce, unannounced and future products, proprietary technical information, and research data used to support a pharmaceutical drug's safety and effectiveness. See, e.g., Westinghouse Elec. Corp. v. Schlesinger, 392 F. Supp. 1246, 1249 (E.D. Va. 1974), aff'd, 542 F.2d 1190 (4th Cir. 1976); SMS, 1989 WL 201031, at *4; Citizen Comm'n, 1993 WL 1610471, at **9-10. Release of such confidential business information could cause competitive harm by permitting competitors to benefit without incurring the usual costs associated with product research and development. See Webb, 696 F.2d at 103. As described in this case, release of information in this category would cause Huntingdon and its clients competitive harm by providing its competitors with an unfair advantage in that they could "craft their own development programs" by using this data. (Caulfield Decl. ¶ 44.) Indeed, Mr. Gilmore states that release of this information would permit Huntingdon's competitors to get a "head start" in developing products by enabling them to "expend less time, effort, money, and resources Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 38 of 42 -28- in researching and developing their own competing products," allowing them to market their products sooner and at a lower price. (First Gilmore Decl. ¶ 18.) As for the IACUC and internal memoranda, Mr. Caulfield attests that these documents contain "descriptive and specific information on confidential research programs performed by Huntingdon" as well as "numerous references to the development of study designs and methods, and discussion of the pharmacologic effect of experimental test compounds." (Caulfield Decl. ¶¶ 42-44.) It is clear that release of this information would permit competitors to gain "insight into Huntingdon's operations," thereby unfairly replicating Huntingdon's efforts without incurring any expense. (See id.) Portions of records such as Huntingdon's candid and detailed discussions of the inspection reports, as well as the internal USDA investigatory records, were withheld because these records contain numerous references to proprietary experimental compounds, the release of which could cause competitive harm by permitting Huntingdon's competitors to replicate Huntingdon's research services without expending their own funds. (See id.; see also Banks Decl. ¶¶ 7-8.) Indeed, Mr. Caulfield attests that the "specificity and type of details" in these records, including details on the sequence of events, the numbers of staff assigned to certain tasks, and the time required for task Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 39 of 42 -29- completion, would be of "great value to its competitors" by providing them with "fundamental and critical business intelligence," thereby permitting the competitors to benefit from Huntingdon's "decades of business" without such an corresponding effort. (Caulfield Decl. ¶ 42.) B) Segregation Defendant re-reviewed all fifty-six pages of the IACUC documents in order to segregate and release any information that would not reveal "confidential commercial information about Huntingdon's general business practices and its research operations." (Id. ¶ 4B.) By letter dated June 15, 2005, defendant provided plaintiff with excised copies of the fifty- six pages. (See id.) Ms. Banks attests that the excised information "would reveal confidential commercial information." (Id.) Defendant carefully reviewed internal Huntingdon memoranda and determined that seven pages could be released in part; the remaining thirty-three "contain no reasonably segregable nonexempt information." (Id. ¶ 5G.) The information withheld pertains to test design and methods, confidential communications between Huntingdon and its clients, and candid discussions of Huntingdon's business practices. (See id.; see also Caulfield Decl. ¶ 42.) Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 40 of 42 -30- Regarding internal USDA memoranda, including "correspondence" as well as "observation sheets" discussed in the correspondence, Ms. Banks states that these records were segregated so that "only those portions containing the above- described confidential business information were withheld pursuant to Exemption 4." ( Banks Decl. ¶ 5H.) Therefore, defendant USDA respectfully suggests that the IACUC records, internal Huntingdon memoranda, and internal USDA investigatory memoranda were properly withheld under Exemption 4 and that all nonexempt information was segregated and released. Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 41 of 42 -31- Conclusion For the foregoing reasons, and based on the entire record herein, it is respectfully requested that Defendant's Renewed Motion for Summary Judgment be granted. Respectfully submitted, KENNETH L. WAINSTEIN (D.C. Bar #451058) United States Attorney R. CRAIG LAWRENCE (D.C. Bar #171538) Assistant United States Attorney Dated: August 3, 2005 ANNE D. WORK (D.D. Bar #376314) Attorney-Advisor Office of Information and Privacy United States Department of Justice Flag Building, Suite 570 Washington, DC 20530-0001 (202) 616-5494 Case 1:02-cv-00557-RWR Document 39 Filed 08/03/05 Page 42 of 42