                           UNITED STATES DISTRICT COURT
                           FOR THE DISTRICT OF COLUMBIA

_____________________________________
                                      )
HERBERT THOMAS,                       )
                                      )
            Plaintiff,                )
                                      )
            v.                        )              Civil Action No. 08-0831 (ESH)
                                      )
DEPARTMENT OF HEALTH AND              )
HUMAN SERVICES, FOOD AND              )
DRUG ADMINISTRATION,                  )
                                      )
            Defendant.                )
_____________________________________ )


                         MEMORANDUM OPINION AND ORDER

       This matter is before the Court on defendant’s second motion for summary judgment.

For the reasons stated, defendant’s motion will be granted in part, and defendant will be required

to supplement its declaration.

                                 FACTUAL BACKGROUND

       It is undisputed that plaintiff directed a request under the Freedom of Information Act

(“FOIA”), 5 U.S.C. § 552, to the Food and Drug Administration (“FDA”), which, after plaintiff

narrowed the request, sought

               (1) the name and address of the bank where Biocine Sclavo,
               S.P.A., f/k/a Sclavo, S.P.A. conduct[s] its banking in Italy and the
               United States; and (2) . . . the name and address where Biocine
               Sclavo’s, SPA f/k/a Sclavo’s, SPA sole United States Distributor:
                       VOCO, INC., f/k/[a] SLAVO, INC.
                       5 Mansard Court
                       Wayne, New Jersey 07470
                       Fed. I.D. # 13-27712263
                       SIC # 5129
               conduct[s] its bank transactions in the United States.
Def.’s Mot. for Summ. J., Ex. 1 (Letter from H. Thomas to FDA, July 23, 2007) (“FOIA

Request”).

       Using Biocine Sclavo’s name and license number, defendant searched the FDA databases

it deemed most likely to contain responsive documents: the FDA’s Center for Biologic

Evaluation and Research’s (1) Regulatory Management System – Biologics Licensing

Application database (and its predecessor database), (2) Document Accountability and Tracking

System (and its predecessor database), and (3) records and files transferred to the federal records

system. See Decl. of Susan Frantz-Bohn ¶¶ 1, 7, 8, 10, Feb. 12, 2009 (“Frantz-Bohn Decl.”)

(annexed to Def.’s Mot. for Summ. J.). These searches revealed that Biocine Sclavo had been

issued licenses for thirteen biologics products, all of which were revoked by 1993. Id. ¶ 11. This

search also established that in accordance with the Federal Records Act, all related records had

been transferred to storage at a federal records center, id. ¶ 13, and that records relating to one

license that was revoked in 1979 had since been destroyed in the normal course, id. ¶ 14. In

response to defendant’s request for “all documents relating to [Biocine] Sclavo,” id. ¶ 13, the

federal records center forwarded six boxes containing approximately 15,000 pages of documents,

id. ¶ 15. Six FDA employees spent a total of more than 50 hours searching the six boxes of

documents, and all documents were searched twice by different individuals. Id. ¶¶ 15-16.

Because some of the documents were in Italian, they were also searched specifically for the

Italian words for bank, bank account, bank note, and savings bank. Id. ¶ 17. The search located

no documents containing the name and/or address of a bank used by Biocine Sclavo or its U.S.

distributor. Id. ¶ 18. On this basis, defendant moved a second time for summary judgment.




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       In opposing defendant’s motion for summary judgment, plaintiff raises two issues relating

to the agency’s search. First, citing 21 C.F.R. §§ 20.81 and 20.112 as authority, he asserts that a

license applicant is required to submit the name and address of its U.S. bank, the very

information he is seeking. Pl.’s Opp’n ¶¶ 4, 6. Apparently doubting the adequacy of the FDA’s

review of the records, plaintiff asks this Court to conduct an in camera review of the 15,000

pages of documents retrieved from the federal records center. Id. ¶ 8. In its reply, the FDA states

that the regulations plaintiff cites do not support his contention and that an in camera review is

unwarranted. See Def.’s Reply at 2-3. Second, plaintiff contends that the record does not

establish whether defendant searched for records related to the particular U.S. distributor,

VOCO, Inc. Pl.’s Opp’n ¶ 3. In reply, defendant merely repeats that it “did not find any

documents containing the name and/or address of the bank used by Biocine Sclavo or its U.S.

distributor.” Def.’s Reply at 2.

                                          DISCUSSION

       Under Rule 56 of the Federal Rules of Civil Procedure, a motion for summary judgment

must be granted if the pleadings and evidence on file show that there is no genuine issue of

material fact, and that the moving party is entitled to judgment as a matter of law. Anderson v.

Liberty Lobby, Inc., 477 U.S. 242, 247 (1986). In a FOIA suit, an agency is entitled to summary

judgment once it satisfies its burden of demonstrating that no material facts are in dispute and

that it has conducted a search reasonably calculated to uncover all relevant information, Weisberg

v. Dep’t of Justice, 745 F.2d 1476, 1485 (D.C. Cir. 1984), which either has been released to the

requestor or is exempt from disclosure. Students Against Genocide v. Dep’t of State, 257 F.3d

828, 833 (D.C. Cir. 2001). To challenge such a showing, the non-moving party “must set forth


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specific facts showing that there is a genuine issue for trial,” Fed. R. Civ. P. 56(e), that would

permit a reasonable jury to find in his favor. Laningham v. U.S. Navy, 813 F.2d 1236, 1241

(D.C. Cir. 1987).

       To show that its search was reasonable, the agency must demonstrate that when “viewing

the facts in the light most favorable to the requester, . . . [it] ‘has conducted a search reasonably

calculated to uncover all relevant documents.”’ Steinberg v. United States Dep’t of Justice, 23

F.3d 548, 552 (D.C. Cir. 1994) (quoting Weisberg, 745 F.2d at 1485). The agency must show

that it used “methods which can be reasonably expected to produce the information requested.”

Oglesby v. Dep't of the Army, 920 F.2d 57, 68 (D.C. Cir. 1990); see also Campbell v. United

States Dep't of Justice, 164 F.3d 20, 27 (D.C. Cir. 1998). In assessing the reasonableness of the

search, a court is guided by principles of reasonableness. Oglesby, 920 F.2d at 68. The

reasonableness of a search is not determined by its results, but by the method of the search itself.

Weisberg, 745 F.2d at 1485. A search need not be exhaustive. Miller v. U.S. Dep’t of State, 779

F.2d 1378, 1383 (8th Cir. 1986). “There is no requirement that an agency search every record

system.” Oglesby, 920 F.2d at 68. An agency's failure to find a particular document does not

undermine the determination that the search was adequate. Wilber v. CIA, 355 F.3d 675, 678

(D.C. Cir. 2004); Nation Magazine, Washington Bureau v. United States Customs Serv., 71 F.3d

885, 892 n.7 (D.C. Cir. 1995). Rather,

       the standard of reasonableness which we apply to agency search procedures . . . requires a
       search reasonably calculated to uncover the sought materials. . . . [T]he [agency] is not
       required . . . to account for documents which the requestor has in some way identified if it
       has made a diligent search for those documents in the places in which they might be
       expected to be found . . . .




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Miller, 779 F.2d at 1384-85. However, “if the sufficiency of the agency’s identification or

retrieval procedure is genuinely in issue, summary judgment is not in order.” Weisberg, 627 F.2d

at 370.

The Biocine Sclavo Search and Review

          Plaintiff, relying on 21 C.F.R. §§ 20.81 and 20.112, contends that Biocine Sclavo was

required to submit the information he is seeking. Pl.’s Opp’n ¶¶ 4, 6. Given that defendant did

not produce the information sought, plaintiff doubts both the adequacy of the search and the

review of the documents that were located. The plain text of the regulations on which plaintiff

relies, however, does not require a license applicant to submit the name and address of the

applicant’s U.S. bank. See 21 C.F.R. §§ 20.81, 20.112. In fact, the cited regulations do not relate

even remotely to such a requirement, and the Court is not aware of any such requirement.

Because plaintiff has not shown there is any reason to assume that the FDA ever had a record of

the licensee’s U.S. bank, he has also not shown that there is any basis on which to doubt the

thoroughness of defendant’s search of approximately 15,000 pages of documents. Consequently,

plaintiff has neither identified a genuine issue of material fact on this point nor established that

an in camera review is warranted. As plaintiff raises no other issues with respect to the search

for records related to Biocine Sclavo, summary judgment will be granted with respect to the first

portion of plaintiff’s FOIA request: “(1) the name and address of the bank where Biocine

Sclavo, S.P.A., f/k/a Sclavo, S.P.A. conduct[s] its banking in Italy and the United States.” Def.’s

Mot. for Summ. J., Ex. 1.




                                                 -5-
The VOCO, Inc. Search

       Plaintiff also challenges defendant’s search because it is not clear that defendant searched

its databases for records related to VOCO, Inc. Pl.’s Opp’n ¶ 3. Indeed, defendant’s sworn

statement claims only that it searched by using Biocine Sclavo’s name and license number.

Frantz-Bohn Decl. ¶ 8. It does not claim that it searched for documents by using VOCO, Inc.’s

name and does not explain why, in light of plaintiff’s FOIA request, a search that did not use

VOCO Inc.’s name as a search term was nonetheless one reasonably calculated to uncover all

relevant information. Nor does defendant’s reply squarely address plaintiff’s challenge. It

merely repeats that it “did not find any documents containing the name and/or address of the U.S.

bank used by Biocine Sclavo or its U.S. distributor,” among those documents it retrieved by

using Biocine Sclavo’s name and license number as search terms. See Def.’s Reply at 2. It may

well be the case that defendant’s search was reasonable, but defendant has not provided the

information necessary to support such a determination. Accordingly, summary judgment will be

denied without prejudice as to the second part of plaintiff’s FOIA request:

               (2) . . . the name and address where Biocine Sclavo’s, SPA f/k/a
               Sclavo’s, SPA sole United States Distributor:
                         VOCO, INC., f/k/[a] SLAVO, INC.
                         5 Mansard Court
                         Wayne, New Jersey 07470
                         Fed. I.D. # 13-27712263
                         SIC # 5129
               conduct[s] its bank transactions in the United States.

Def.’s Mot. for Summ. J., Ex. 1. Defendant will be required to supplement its declaration with

respect to the reasonableness of its search for this information.




                                                -6-
                                  CONCLUSION AND ORDER

       For the reasons stated, it is hereby

       ORDERED that defendant’s motion for summary judgment [#22] is GRANTED IN

PART and DENIED WITHOUT PREJUDICE IN PART. It is granted with respect to

plaintiff’s request for information relating to Biocine Sclavo, and it is denied as to plaintiff’s

request for information relating to VOCO, Inc. It is

       FURTHER ORDERED that on or before August 27, 2009, defendant shall file a

supplement to its declaration explaining why its search using only the Biocine Sclavo firm’s

name and license number was reasonably calculated to uncover all relevant information

requested in the second part of plaintiff’s FOIA request. If plaintiff has any further objection to

defendant’s supplement, he must file his opposition on or before September 15, 2009.



                                                                   /s/
                                                       ELLEN SEGAL HUVELLE
                                                       United States District Judge

Date: August 11, 2009




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