Msj

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

____________________________________ Brian S. Hooker, Ph.D., P.E. ) ) Plaintiff, ) ) v. ) ) Kathleen Sebelius, as Secretary ) Civil A. No. 11-cv-01276 (ABJ) of the United States Department ) of Health and Human Services, )

) and ) ) Thomas R. Frieden, MD, MPD, ) as Director of the Centers for Disease ) Control and Prevention ) ___________________________________________)

DEFENDANTS’ MOTION FOR SUMMARY JUDGMENT

Plaintiff, Dr. Brian S. Hooker, brought this action against Defendants Kathleen Sebelius,

Secretary of the U.S. Department of Health and Human Services (“HHS”) and Thomas R.

Frieden, Director of the Centers for Disease Control and Prevention (“CDC”) (together,

“Defendants”), under the Freedom of Information Act (“FOIA”), 5 U.S.C. § 552, as amended,

challenging CDC’s response to four FOIA requests that Plaintiff submitted via emails on March

11, 2005 (Count 1), April 20, 2005 (Count 2), April 23, 2005 (Count 3), and December 4, 2004

(Count 4).

As of the date of this filing, HHS and CDC have satisfied all of their obligations with

respect to Plaintiff’s above-referenced FOIA requests. Defendants have conducted an adequate

search for responsive records and have released to Plaintiff all of the responsive records to which

Plaintiff is entitled. As there are no material facts in dispute, Defendants respectfully move this

Court pursuant to Federal Rule of Civil Procedure 56 for summary judgment as to all claims

asserted in this action. Defendants respectfully submit that the attached memorandum of points

Case 1:11-cv-01276-ABJ Document 11 Filed 11/04/11 Page 1 of 33

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and authorities, supporting declaration, and exhibits thereto establish that Defendants are entitled

to the relief they are seeking.

Respectfully submitted,

RONALD C. MACHEN Jr. United States Attorney RUDOLPH CONTRERAS, Chief, Civil Division By: /s/ Harry B. Roback HARRY B. ROBACK, D.C. Bar # 485145 Assistant United States Attorney United States Attorneys Office 555 4th Street, N.W. Washington, D.C. 20530 Tel: 202-616-5309 [email protected] November 4, 2011 Counsel for Defendants




) and ) ) Thomas R. Frieden, MD, MPD, ) as Director of the Centers for Disease ) Control and Prevention ) ____________________________________)

DEFENDANTS’ STATEMENT OF MATERIAL FACTS NOT IN DISPUTE

Pursuant to Local Civil Rule 7(h), Defendants Kathleen Sebelius, Secretary of the U.S.

Department of Health and Human Services (“HHS”) and Thomas R. Frieden, Director of the

Centers for Disease Control and Prevention (“CDC”) respectfully submit this Statement of

Material Facts Not in Dispute.

COUNT 1

1. On March 15, 2005, Dr. Brian S. Hooker electronically submitted a FOIA request for all

written correspondence regarding two studies: (a) “Thimerosal and the Occurrence of Autism:

Negative Ecological Evidence From Danish Population-Based Data,” and (b) “Association

between Thimerosal Containing Vaccine and Autism.” See Declaration of Carol Maloney

(“Maloney Decl.”) ¶ 2.


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2. CDC responded on April 6, 2005, via letter, and informed Dr. Hooker that the estimated

cost of processing his request was $1,394.00. Id. ¶ 4. Dr. Hooker subsequently remitted

$1,394.00. Id.

3. Dr. Hooker’s request was sent to the National Immunization Program (NIP), the National

Center for Birth Defects and Developmental Disabilities (NCBDDD), the National Center for

Environmental Health (NCEH), and the Office of the Executive Secretariat (OES) for

processing. Id. ¶ 8. These offices were the reasonably likely locations of the records sought by

Dr. Hooker and were identified in Dr. Hooker’s request. Id.

4. There were no other likely locations of records responsive to Dr. Hooker’s request. Id. ¶

9.

5. Program staff in each of the offices searched for the records sought by Dr. Hooker. Id. ¶

10. The NIP did not find any responsive records. Id.

6. On June 24, 2005, CDC provided an interim response in which it released documents and

informed Dr. Hooker that CDC was still processing his request. Id. ¶ 11. CDC also informed Dr.

Hooker that it was withholding some documents under Exemptions 5 and 6. Id.

7. On July 17, 2005, Dr. Hooker appealed the decision in the June 24, 2005 letter. Id. ¶ 12.

This appeal was assigned number PHS-2K5-A-105. Id. ¶ 12.

8. On September 1, 2005, CDC provided a second interim response in which it informed Dr.

Hooker that the NCBDDD was still processing his request and the NIP had completed its search

and did not find any records responsive to his request. Id. ¶ 13.

9. On September 8, 2005, Dr. Hooker appealed the decision in the September 1, 2005, letter.

Id. ¶ 14. This appeal was assigned number PHS-2K5-A-121. Id.


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10. On October 31, 2005, CDC provided its final response to Dr. Hooker in which it released

certain documents and withheld certain documents. Id. ¶ 14.

11. On November 16, 2005, Dr. Hooker appealed the decision in the October 31, 2005, letter.

Id. ¶ 16. This appeal was assigned the number PHS-2K6-A-017. Id.

12. On September 8, 2006, CDC released additional documents to Dr. Hooker. Id. ¶ 17.

13. CDC’s search was upheld on appeal, as were withholdings and redactions pursuant to

Exemptions 5 and 6. Id. ¶ 19.

14. The documents withheld or redacted under Exemption 5 consist of internal e-mail

communication discussing edits to draft manuscripts, data underlying manuscripts, and

publication of draft manuscripts; reviewer comments; and draft correspondence. Id. ¶ 22.

15. The correspondence withheld or redacted under Exemption 5 were among CDC

employees and Poul Thorsen, Kreesten Madsen, Marlene Lauritsen, and Preben Mortensen.

These four individuals were authors of a manuscript entitled “Thimerosal and the Occurrence of

Autism: Negative Ecological Evidence From Danish Population-Based Data.” Id. ¶ 23. CDC

collaborated with the authors of this manuscript and, therefore, the authors were considered

temporary consultants to the CDC. Id.

16. The portions withheld or redacted under Exemption 5 are intra-agency discussions that

would not be available to a party in civil litigation. Id. ¶ 24.

17. The CDC redacted the mobile phone number of Kreesten Madsen and comments

regarding Poul Thorsen's personal life pursuant to Exemption 6. Id. ¶ 25.

18. In asserting Exemption 6, each piece of information was scrutinized to determine the

nature and strength of the privacy interest of any individual whose name or identifying

information appeared in the documents at issue. In each instance where information was


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withheld, the individual had a privacy interest in the information being withheld pursuant to

Exemption 6. Id. ¶ 26. Disclosure of this information would constitute an invasion of privacy of

these individuals.

19. CDC evaluated the privacy interest inherent in each piece of information against the

public interest in disclosure of shedding light on HHS’s performance of its statutory duties. Id. In

withholding the information, the individual’s privacy interests outweighed any public interest in

disclosure of the withheld information. Id. Disclosure of the withheld information would reveal

nothing about the operations or activities of HHS, or any component thereof. Id.

20. There is no public interest in Kreesten Madsen’s mobile phone number or Poul Thorsen’s

personal life. Id. As the privacy interests outweigh any public interest in disclosure, release of

this information would constitute a clearly unwarranted invasion of personal privacy. Id.

21. For each document that was withheld or redacted, a line-by-line review was completed to

determine whether any portions of the documents could be released. Id. ¶ 27. For each document

that was withheld in its entirety, it was determined that there was no reasonably segregable, non-

exempt information in this document, because any non-exempt information would leave only

meaningless words and phrases. Id.

COUNTS TWO AND THREE

22. On April 20, 2005, Dr. Hooker electronically submitted a FOIA request seeking all

correspondence between Dr. Sarah Parker and Dr. James Todd of the University of Colorado

Health Sciences Center and NIP researchers, and all correspondence among NIP researchers,

regarding the publication “Thimerosal-Containing Vaccines and Autistic Spectrum Disorder: A

Critical Review of Published Original Data.” Id. ¶ 28. This request was assigned number 05-

674. Id.


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23. On April 23, 2005, Dr. Hooker electronically submitted a FOIA request seeking all

correspondence between Dr. Thomas Verstaeten and all CDC employees in the NIP and the

Office of the Director from July 2001 until the date of the request. Id. ¶ 29. This request was

assigned number 05-680. Id.

24. In a letter dated May 25, 2005, CDC informed Dr. Hooker that it was aggregating his two

requests. Id. ¶ 30. CDC further informed Dr. Hooker that the estimated costs to process his

request was $835.50. Id.

25. The CDC determined that the NIP and the National Center for Infectious Diseases

(NCID) were the reasonably likely locations of the records sought by Dr. Hooker. Id. ¶ 31. In

both requests, Dr. Hooker specifically stated that he was seeking correspondence with employees

of the NIP. Id.

26. The NCID did not have any responsive records. Frank Destefano, William Thompson,

Larry Pickering, and Robert Chen, of the NIP, searched for responsive records. Id. Additionally,

Dr. Dixie Snider, in the Office of the Chief of Science, searched for records and found none. Id.

Id. ¶ 32.

27. CDC provided a final response on September 9, 2005. Id. ¶ 33. In response to request

05-674, CDC officials found five responsive documents, all of which were withheld under

Exemption 5. Id. In response to request 05-680, CDC released some documents and withheld

documents under Exemptions 2, 4, and 5. Id. CDC also withheld documents that were protected

by the Copyright Act. Id.

28. Dr. Hooker appealed this determination on October 4, 2005. Id. ¶ 34. Regarding request

05-674, Dr. Hooker stated that the documents were withheld in violation of OMB Circular 110,

rev. 99, section 36. Id. Regarding Request 05-680, Dr. Hooker questioned why the original


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invoice estimated that there would be 1760 pages but only 300 were released. Id. Dr. Hooker

also challenged the redactions and withholdings made. Id.

29. HHS acknowledged receipt of Dr. Hooker’s appeal on October 5, 2005 and assigned it

number PHS-2K6-A-001. Id. ¶ 35.

30. HHS provided a final response on November 4, 2005. Id. ¶ 36. Regarding request 05-

674, HHS determined to release all of the withheld documents subject to two minor redactions

under Exemption 6. Id.

31. Regarding request 05-680, the review on appeal discovered that the original estimate of

1760 pages was inaccurate; the actual number of responsive documents found was 613 pages, of

which 319 were withheld in their entirety. Id. ¶ 37.

32. It was determined that CDC correctly withheld and redacted information under

Exemption 5. Id. ¶ 38. It was also determined that CDC correctly withheld documents that were

protected by the Copyright Act. Id. HHS determined that two pages of documents were

incorrectly withheld under Exemption 4 and released those documents in full. Id. ¶ 26. HHS

also determined that withholdings under Exemption 2 were improper, but Exemption 6 protected

the information.

33. The documents withheld or redacted under Exemption 5 consist of draft manuscripts;

internal e-mail communication discussing edits to draft manuscripts, data underlying

manuscripts, and publication of draft manuscripts; reviewer comments; and draft

correspondence. Id. ¶ 41.

34. Draft manuscripts and correspondence are by their nature pre-decisional and deliberative.

In this case, draft manuscripts and correspondence were circulated for comment and

consideration of whether any changes should be made before publication. Id. ¶ 42.


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35. Reviewer comments are used by the CDC to determine whether to seek publication of a

manuscript and provide guidance with respect to revision of the manuscript. Id.

36. The correspondence withheld or redacted under Exemption 5 were among Thomas

Verstraeten, Robert L. Davis, Frank DeStefano, Tracy A. Leiu, Phillip H. Rhodes, Steven B.

Black, Henry Shinfield, Robert T. Chen, William Thompson, Julianna Gee, Brooke Barry,

Walter Orenstein, Melinda Wharton and David Shay. Id. ¶ 43.

37. Frank Destefano, Robert Chen, David Shay, Phillip Rhodes, Julianna Gee, Brooke Barry,

Walter Orenstein, Melinda Wharton and William Thompson were CDC employees during the

time periods relevant to Plaintiff’s FOIA request. Id. ¶ 44.

38. Robert Davis, Tracy Leiu, Steven Black, and Henry Shinefield were outside researchers

collaborating with the CDC on a manuscript entitled “Safety of Thimerosal-Containing

Vaccines: A Two-Phased Study of Computerized Health Maintenance Organization Databases.”

Id. ¶ 45. CDC employees Robert Chen, Frank Destefano, and Phillip Rhodes were also co-

authors of this manuscript. Id. CDC collaborated with the authors of this manuscript and,

therefore, the authors were considered temporary consultants to the CDC. Id.

39. Dr. Thomas Verstraeten was also a co-author on this manuscript. Id. ¶ 46. Dr. Verstraeten

was a CDC employee when he began working on this, and other, manuscripts that are the subject

of the withheld or redacted emails. Id. Dr. Verstraeten left CDC in 2001 to work in the private

sector, but continued to work on the manuscripts he co-authored after leaving CDC. Id.

40. The portions withheld and redacted under Exemption 5 are intra-agency discussions that

would not be available to a party in civil litigation and were properly withheld. Id. ¶ 47.


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41. The CDC redacted the email addresses, and other contact information, of individuals and

other personal information, including discussions of an individual’s personal life and travel plans

under Exemption 6. Id. ¶ 48.

42. In asserting Exemption 6, each piece of information was scrutinized to determine the

nature and strength of the privacy interest of any individual whose name or identifying

information appeared in the documents at issue. Id. ¶ 49. In each instance where information

was withheld, the individual had a privacy interest in the information being withheld pursuant to

Exemption 6. Id. Disclosure of this information would constitute an invasion of privacy of these

individuals. Id.

43. In addition, CDC evaluated the privacy interest inherent in each piece of information

against the public interest in disclosure and shedding light on HHS’s performance of its statutory

duties. Id. In withholding the information, the individual’s privacy interests outweighed any

public interest in disclosure of the withheld information. Id. Disclosure of the withheld

information would reveal nothing about the operations or activities of HHS, or any component

thereof. Id. There is no public interest in the contact information of individuals outside the

CDC, nor is there a public interest in comments regarding an individual’s personal life or travel

plans. Id. As the privacy interests outweigh any public interest in disclosure, release of this

information would constitute a clearly unwarranted invasion of personal privacy. Id.

44. CDC also withheld certain documents that are protected by the Copyright Act. Id. ¶ 50.

For each of these documents, the Vaughn index provides the title and other identifying

information, such that Plaintiff can obtain copies of the copyrighted materials through other

avenues. Id.


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45. For each document that was withheld or redacted, a line-by-line review was completed to

determine whether any portions of the documents could be released. Id. ¶ 51. For each document

that was withheld in its entirety, it was determined that there was no reasonably segregable, non-

exempt information in this document, because any non-exempt information would leave only

meaningless words and phrases. Id.

COUNT FOUR

46. On or about December 14, 2004, Dr. Hooker electronically submitted a FOIA request

seeking all correspondence between Elizabeth Miller and/or Nick Andrews and CDC employees

regarding the Miller and Andrews study presented at the February 9, 2004, IOM Vaccine Safety

Review Committee Meeting. Id. ¶ 52. This request was assigned number 05-0222. Id.

47. The FOIA request was forwarded the same day to the NIP. Id. ¶ 53. A search for records

was performed by various staff members who were familiar with NIP files. Id.

48. CDC staff determined that the NIP was the reasonably likely location of the records

sought by Dr. Hooker. Id. ¶ 54.

49. On December 29, 2004, Dr. Hooker expanded the scope of his original request via email

by adding Brent Taylor to the list of researchers whose correspondence he was seeking. Id. ¶ 55.

The expanded request was also sent to NIP for processing. Id. ¶ 56.

50. During the course of the search, CDC learned that Dr. Chen, an NIP employee, had

received emails responsive to Dr. Hooker’s request. Id. ¶ 57. Dr. Chen, however, did not retain

his replies to those emails. Id.

51. The CDC responded via a letter on January 31, 2005. Id. ¶ 58. The CDC released all

documents which it identified as responsive to Dr. Hooker’s request and specifically noted that it


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Dr. Chen did not retain replies to the responsive emails. Id. CDC did not withhold any

documents. Id.

52. On or about February 23, 2005, Dr. Hooker appealed this decision and challenged

whether Dr. Chen had additional emails that were not released. Id. ¶ 59.

53. After receipt of the appeal, CDC conducted an additional search of the NIP files and did

not locate additional emails. Id. ¶ 60. CDC also confirmed with Dr. Chen that he did not have

any additional emails. Id. ¶ 61. This was communicated to Dr. Hooker via a letter dated July 19,

2005. Id. ¶ 62.

Respectfully submitted, RONALD C. MACHEN Jr. United States Attorney RUDOLPH CONTRERAS, Chief, Civil Division By: /s/ Harry B. Roback HARRY B. ROBACK, D.C. Bar # 485145 Assistant United States Attorney United States Attorneys Office 555 4th Street, N.W. Washington, D.C. 20530 Tel: 202-616-5309 [email protected] November 4, 2011 Counsel for Defendants




) and ) ) Thomas R. Frieden, MD, MPD, ) as Director of the Centers for Disease ) Control and Prevention ) ____________________________________)

MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF DEFENDANTS’ MOTION FOR SUMMARY JUDGMENT

Plaintiff Dr. Brian S. Hooker, brought this action against Defendants Kathleen Sebelius,

Secretary of the U.S. Department of Health and Human Services (“HHS”) and Thomas R.

Frieden, Director of the Centers for Disease Control and Prevention (“CDC”) (together,

“Defendants”), under the Freedom of Information Act (“FOIA”), 5 U.S.C. § 552, as amended,

challenging CDC’s response to four FOIA requests that Plaintiff submitted via emails dated

March 11, 2005 (Count 1), April 20, 2005 (Count 2), April 23, 2005 (Count 3), and December 4,

2004 (Count 4).

As of the date of this filing, HHS and CDC have satisfied all of their obligations with

respect to Plaintiff’s above-referenced FOIA requests. Defendants have conducted an adequate

search for responsive records and have produced to Plaintiff all of the responsive records to

which Plaintiff is entitled. As there are no material facts in dispute, Defendants respectfully


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move this Court pursuant to Federal Rule of Civil Procedure 56 for summary judgment as to all

claims asserted in this action.

BACKGROUND

I. PLAINTIFF’S FOIA REQUESTS

On March 11, 2005, Plaintiff submitted a FOIA request to the CDC FOIA Office. In his

request, Plaintiff sought:

All written correspondences both between ALL CDC employees and between ALL CDC employees and ALL outside persons regarding the thimerosal and autism study completed using the Danish Psychiatric Central Research Register by Kreesten Madsen (From the Danish Epidemiology Science Center, Department of Epidemiology and Social Medicine, University of Aarhus, Denmark) as reported in the publication: “Thimerosal and the Occurrence of Autism: Negative Ecological Evidence From Danish Population-Based Data,” Madsen et al. 2003 Pediatrics 112:604-606, as well as ALL written correspondences both between ALL CDC employees and between ALL CDC employees and ALL outside persons regarding the thimerosal and autism study completed using the Danish Psychiatric Central Research Register and the Danish Civil Registration System by Anders Hviid) From the Danish Epidemiology Science Centre, Department of Epidemiology Research, State Serum Institute, Copenhagen, Denmark) as reported in the publication “Association between Thimerosal Containing Vaccine and Autism.” Hviid et al. 2003 JAMA 290:1763-1766.”

Maloney Decl. ¶ 6 & Ex. B. The FOIA request then listed individuals who may have participated

in the correspondence sought by Plaintiff. Id.

On April 20, 2005, Plaintiff submitted a FOIA request to the CDC FOIA office, in which

he sought:

All written correspondences between Dr. Sarah Parker and Dr. James Todd of the University of Colorado Health Sciences Center and NIP researchers regarding the publication and studies that led to the publication: “Thimerosal-Containing Vaccines and Autistic Spectrum Disorder: A Critical Review of Published Original Data,” 2004 Pediatrics 114:793. All written correspondences among NIP researchers regarding the publication above. The search for correspondences should include those between 1/1/2002 and the present.


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Id. ¶ 28 & Ex. P. The FOIA request then listed individuals who may have participated in the

correspondence sought by Plaintiff. Id.

On April 23, 2005, Plaintiff submitted a FOIA request to the CDC FOIA office, in which

he sought “all correspondences between Dr. Thomas Verstraeten, after he left the CDC in July

2001 to the present, and all CDC employees in the NIP and the Office of the Director.” Id. ¶ 29

& Ex. Q. The FOIA request then listed individuals who may have participated in the

correspondences sought by Plaintiff. Id.

On December 14, 2004, Plaintiff submitted a FOIA request to the CDC FOIA office in

which he sought any correspondence between Elizabeth Miller and/or Nick Andrews and CDC

employees up to the date of the presentation of the Miller and Andrews study presented at the

February 9, 2004, IOM Vaccine Safety Review Committee meeting. Id. ¶ 52 & Ex. W. On

December 29, 2004, Plaintiff amended his request to also add Brent Taylor to the list of

researcher whose correspondence he was seeking. Id. ¶ 55 & Ex. X.

II. HHS’S SEARCH FOR AND DISCLOSURE OF RECORDS RESPONSIVE TO PLAINTIFF’S FOIA REQUEST .

A. CDC’s Search for Responsive Records

Upon receipt of Plaintiff’s FOIA requests, CDC conducted searches for responsive

records in places reasonably likely to contain responsive records. Plaintiff’s first FOIA request,

identified in Count 1, sought communications between CDC employees and outside persons

regarding two publications. Maloney Decl. ¶ 6 & Ex. B. Dr. Hooker’s request was sent to the

National Immunization Program (NIP), the National Center for Birth Defects and Developmental

Disabilities (NCBDDD), the National Center for Environmental Health (NCEH), and the Office

of the Executive Secretariat (OES) for processing. Id. ¶ 8. These offices were the reasonably

likely locations of the records sought by Dr. Hooker and were identified in Dr. Hooker’s request.


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There were no other likely locations of records responsive to Dr. Hooker’s request. Id. ¶ 9.

Program staff in each of the offices searched for the records sought by Dr. Hooker. Id. ¶ 10.1

Plaintiff’s second FOIA request, identified in Count 2, sought correspondence between

Dr. Sarah Parker and Dr. James Todd of the University of Colorado Health Sciences Center and

NIP, and among researchers in the NIP. Id. ¶ 28 & Ex. P. Plaintiff’s third FOIA request sought

“all correspondences between Dr. Thomas Verstraeten, after he left the CDC in July 2001 to the

present, and all CDC employees in the NIP and the Office of the Director.” Id. ¶ 29 & Ex. S.

These two requests were aggregated and forwarded to the NIP and the National Center on

Infectious Diseases (NCID), whose staff searched for responsive records.2 Id. ¶ 32. The NIP was

the reasonably likely location of the records sought by Dr. Hooker because in both requests, Dr.

Hooker specifically stated that he was seeking correspondence with employees of the NIP. Id. ¶

31. The NCID did not have any responsive records. Frank Destefano, William Thompson,

1 The NIP did not find any responsive records. Maloney Decl. ¶ 10. 2 Plaintiff has not challenged the search for records, but has referenced OMB Circular 11, rev. 99, section 36 as a basis for arguing that Defendant has not provided adequate documents in response to his FOIA request. The provision cited by Plaintiff has been codified at 45 CFR § 74.36. This provision provides that “in response to a Freedom of Information Act (FOIA) request for research data relating to published research findings produced under an award that were used by the Federal Government in developing an agency action that has the force and effect of law, the HHS Awarding Agency shall request, and the recipient shall provide, within a reasonable time, the research data so that they can be made available to the public through the procedures established under the FOIA.” 45 CFR § 74.36(d)(1). For purposes of this section, research data is defined as “the recorded factual material commonly accepted in the scientific community as necessary to validate research findings, but not any of the following: preliminary analyses, drafts of scientific papers, plans for future research, peer reviews, or communications with colleagues.” 45 CFR § 74.36(d)(2) (emphasis supplied). Plaintiff has not requested any research data. His FOIA request expressly sought “written correspondences” between the authors and NIP researchers. “Communications with colleagues” are excluded from the definition of research data. Moreover, Plaintiff can point to no “agency action that has the force and effect of law” that was developed based upon the manuscript. 45 CFR § 74.36(d)(2)(iii) (“Used by the Federal Government in developing an agency action that has the force and effect of law is defined as when an agency publicly and officially cites the research findings in support of an agency action that has the force and effect of law.”)


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Larry Pickering, and Robert Chen, of the NIP, searched for responsive records. Additionally, Dr.

Dixie Snyder, in the Office of the Chief of Science, searched for records and found none. Id. ¶

32.

Plaintiff’s fourth FOIA request sought correspondence between Elizabeth Miller and/or

Nick Andrews and CDC employees up to the date of the presentation of the Miller and Andrews

study presented at the February 9, 2004, IOM Vaccine Safety Review Committee meeting.

Maloney Decl. ¶ 52. & Ex. W. On December 29, 2004, Plaintiff amended his request to also add

Brent Taylor to the list of researchers whose correspondence he was seeking. Id. ¶ 55 & Ex. X.

Both requests were forward to the NIP, whose program staff searched for responsive records. Id.

¶¶ 53 & 55. CDC staff determined that the NIP was the reasonably likely location of the records

sought by Dr. Hooker. Id. ¶ 54. Plaintiff challenged this search, on the grounds that he was not

provided outgoing emails from Dr. Robert Chen. Id. ¶ 59. CDC conducted an additional search

after receiving the appeal and confirmed that Dr. Chen did not have additional records. Id. ¶ 60.

B. CDC’s Withholdings Pursuant to Exemptions 5, 6, and the Copyright Act

As indicated in the Vaughn Index attached as Exhibit A to the Maloney Declaration,

CDC redacted or withheld information exempt from disclosure pursuant to FOIA Exemptions 5

and 6. Maloney Decl. ¶¶ 15 & 33. Additionally, CDC withheld certain documents that are

protected by the Copyright Act. Id. Specifically, CDC withheld under Exemption 5 internal

Agency e-mails, drafts, and other documents related to the publication of certain manuscripts.

Id. ¶¶ 22 & 41. CDC withheld under Exemption 6 contact information for a number of

researchers, and withheld some discussions of personal issues in emails. Id. ¶ 25 & 48. Finally,

CDC withheld copies of 4 articles that are subject to the Copyright Act. Id. ¶ 50.


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STANDARD OF REVIEW

Summary judgment is appropriate when the pleadings and evidence “show that there is

no genuine issue as to any material fact and that the moving party is entitled to judgment as a

matter of law.” Fed. R. Civ. P. 56(c); Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247 (1986);

Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986); Tao v. Freeh, 27 F.3d 635, 638 (D.C. Cir.

1994). The party seeking summary judgment must demonstrate the absence of a genuine issue of

material fact. See Celotex, 477 U.S. at 248. A genuine issue of material fact is one that “might

affect the outcome of the suit under the governing law.” Anderson, 477 U.S. at 248. Once the

moving party has met its burden, the nonmoving party “may not rest upon the mere allegations

or denials of his pleading, but . . . must set forth specific facts showing that there is a genuine

issue for trial.” Anderson, 477 U.S. at 248.

FOIA cases are typically and appropriately decided on motions for summary judgment.

Citizens for Responsibility & Ethics in Washington v. U.S. Dep’t of Labor, 478 F. Supp. 2d 77,

80 (D.D.C. 2007) (“CREW”); Wheeler v. Dep’t of Justice, 403 F. Supp. 2d 1, 5-8 (D.D.C. 2005).

An agency may be entitled to summary judgment in a FOIA case if it demonstrates that no

material facts are in dispute, it has conducted an adequate search for responsive records and each

responsive record that it has located either has been produced to the plaintiff or is exempt from

disclosure. See Weisberg v. Dep’t of Justice, 627 F.2d 365, 368 (D.C. Cir. 1980). To meet its

burden, a defendant may rely on reasonably detailed and non-conclusory declarations. See

McGehee v. C.I.A., 697 F.2d 1095, 1102 (D.C. Cir. 1983); Vaughn v. Rosen, 484 F.2d 820 (D.C.

Cir. 1973), cert denied, 415 U.S. 977 (1974); Wheeler, 403 F. Supp. 2d at 6. “[T]he Court may

award summary judgment solely on the basis of information provided by the department or

agency in declarations when the declarations describe ‘the documents and the justifications for


7

nondisclosure with reasonably specific detail, demonstrate that the information withheld

logically falls within the claimed exemption, and are not controverted by either contrary

evidence in the record nor by evidence of agency bad faith.’” CREW, 478 F. Supp. 2d at 80

(quoting Military Audit Project v. Casey, 656 F.2d 724, 738 (D.C. Cir. 1981)). Here, CDC has

submitted the Declaration of Carol Maloney, which is reasonably detailed and accompanied by a

supporting Vaughn index, to explain and justify the agency’s responses to Plaintiff’s FOIA

request.

ARGUMENT

I. PLAINTIFF HAS FAILED TO NAME A PROPER PARTY DEFENDANT

Plaintiff has failed to name a proper defendant for the FOIA claim. The only proper party

defendant in a FOIA lawsuit is a federal agency. See 5 U.S.C. § 552(a)(4)(B) (granting district

courts “jurisdiction to enjoin the agency from withholding agency records improperly withheld

from complainant”); 5 U.S.C. § 552(f)(1) (defining the term “agency”); see also Dunleavy v.

New Jersey, 251 F. App’x 80, 83 (3d Cir. 2007) (upholding district court's decision to dismiss

FOIA claim against state agency). The heads of agencies or agency officials are not federal

agencies within the meaning of FOIA. See, e.g., Martinez v. BOP, 444 F.3d 620, 624 (D.C. Cir.

2006) (affirming district court’s decision to dismiss FOIA claims against individual federal

employees); Thompson v. Walbran, 990 F.2d 403, 405 (8th Cir. 1993) (per curiam) (dismissing

suit brought against prosecutor, because plaintiff “sued the wrong party”); Petrus v. Bowen, 833

F.2d 581, 582 (5th Cir. 1987) (“Neither the Freedom of Information Act nor the Privacy Act

creates a cause of action for a suit against an individual employee of a federal agency.”); Ginarte

v. Mueller, 534 F. Supp. 2d 135, 137 (D.D.C. 2008) (dismissing FOIA claims against individual

officers at federal agency, because they are not proper party defendants); Santini v. Taylor, 555


8

F. Supp. 2d 181, 184 (D.D.C. 2008) (dismissing FOIA complaint for lack of subject matter

jurisdiction because plaintiff named government employees as defendants, rather than agency).

Defendants Sebelius and Frieden are not federal agencies. Therefore, plaintiff has not named a

proper defendant for this FOIA lawsuit. The Court could dismiss the case on this ground.

Alternatively, HHS has no objection to the Court substituting it as the proper party-defendant.

II. HHS PROPERLY RELEASED ALL RESPONSIVE, NON-EXEMPT RECORDS IN RESPONSE TO PLAINTIFF’S FOIA REQUESTS

The FOIA requires that an agency release all records responsive to a properly submitted

request unless such records are protected from disclosure by one or more of the Act’s nine

exemptions. 5 U.S.C. § 552(b); U.S. Dep’t of Justice v. Tax Analysts, 492 U.S. 136, 150-51

(1989). Once the court determines that an agency has released all nonexempt material, it has no

further judicial function to perform under the FOIA and the FOIA claim is moot. Perry v. Block,

684 F.2d 121, 125 (D.C. Cir. 1982); Muhammad v. U.S. Customs & Border Prot., 559 F.

Supp.2d 5, 7-8 (D.D.C. 2008). As demonstrated below, HHS conducted adequate searches for

records responsive to Plaintiff’s FOIA requests and properly withheld information pursuant to

Exemptions 5 and 6, and the Copyright Act.

A. HHS Conducted Searches Reasonably Calculated to Uncover All Relevant Documents in Response to Plaintiff’s FOIA Requests

Under the FOIA, an agency must undertake a search that is “reasonably calculated to

uncover all relevant documents.” Weisberg v. Dep’t of Justice, 705 F.2d 1344, 1351 (D.C. Cir.

1983). An agency’s search for records is adequate if it was “reasonably calculated to uncover all

relevant documents.” Valencia-Lucena v. U.S. Coast Guard, 180 F.3d 321, 325 (D.C. Cir. 1999)

(internal quotation marks omitted); see Oglesby v. Dep’t of the Army, 920 F.2d 57, 68 (D.C. Cir.

1990) (“[T]he agency must show that it made a good faith effort to conduct a search for the


9

requested records, using methods which can be reasonably expected to produce the information

requested.”). A search is not inadequate merely because it failed to “uncover[] every document

extant.” SafeCard Servs., Inc. v. S.E.C., 926 F.2d 1197, 1201 (D.C. Cir. 1991). Rather, a search

is inadequate only if the agency fails to “show, with reasonable detail, that the search method . . .

was reasonably calculated to uncover all relevant documents.” Oglesby, 920 F.2d at 68. Once

an agency demonstrates the adequacy of its search, the agency’s position can be rebutted “only

by showing that the agency’s search was not made in good faith.” Maynard v. C.I.A., 986 F.2d

547, 560 (1st Cir. 1993). Hypothetical assertions are insufficient to raise a material question of

fact with respect to the adequacy of an agency’s search. Oglesby, 920 F.2d at 67 n.13. “Agency

affidavits enjoy a presumption of good faith that withstands purely speculative claims about the

existence and discoverability of other documents.” Chamberlain v. U.S. Dep’t of Justice, 957 F.

Supp. 292, 294 (D.D.C. 1997), aff’d, 124 F.3d 1309 (D.C. Cir. 1997).

Here, the Declaration of Carol Maloney establishes that CDC’s search method was

reasonably calculated to uncover all records in its possession responsive to Plaintiff’s FOIA

request. Each time CDC received a FOIA request from Dr. Hooker, it determined which offices

were the reasonably likely locations of responsive records. Maloney Decl. ¶¶ 8-9, 31, 54.

Program staff in each office conducted a search for responsive records. Id. ¶¶ 10, 32, 5.

Additionally, after Plaintiff challenged CDC’s search for records responsive to request 05-0222

(Count 4), CDC conducted an additional search and did not locate any new records. Id. ¶ 60. As

demonstrated above, CDC plainly conducted an adequate search for records in response to

Plaintiff’s FOIA request. See Oglesby, 920 F.2d at 68 (holding that a search need only “us[e]

methods which can be reasonably expected to produce the information requested”).


10

B. CDC Properly Asserted Exemption 5

FOIA Exemption 5 protects from disclosure “inter-agency or intra-agency memorandums

or letters which would not be available by law to a party . . . in litigation with the agency.” 5

U.S.C. § 552(b)(5). Thus, documents that would ordinarily be privileged in the civil discovery

context are protected from public disclosure. See Nat’l Labor Relations Bd. v. Sears, Roebuck &

Co., 421 U.S. 132, 148-149 (1975) (Exemption 5 protects documents that would be privileged as

deliberative process, attorney-client communications, and attorney work product); Martin v.

Office of Special Counsel, 819 F.2d 1181, 1184-87 (D.C. Cir. 1987). In particular, the purpose

of the deliberative process privilege is to “prevent injury to the quality of agency decisions.”

Sears, 421 U.S. at 151. The privilege applies regardless of whether the deliberations involve

attorneys or litigation is anticipated. It covers documents “reflecting advisory opinions,

recommendations and deliberations comprising part of a process by which governmental

decisions and policies are formulated,” id. at 150, as well as “recommendations, draft documents,

proposals, suggestions, and other subjective documents which reflect the personal opinions of the

writer rather than the policy of the agency,” Citizens for Responsibility and Ethics v. Dep’t of

Labor, 478 F. Supp. 2d 77, 81 (D.D.C. 2007) (quoting Coastal States Gas Corp. v. Dep’t of

Energy, 617 F.2d 854, 866 (D.C. Cir. 1980)). It also protects factual materials that are closely

intertwined with opinions, recommendations, and deliberations. Mapother v. Dep’t of Justice, 3

F.3d 1533, 1538-1539 (D.C. Cir. 1993).

The threshold requirement under Exemption 5 is that records be “inter-agency or intra-

agency memorandums.” Judicial Watch, Inc. v. United States Dep’t of Commerce, 90 F. Supp.2d

9, 13 (D.D.C. 2000). If the threshold is met, to qualify for protection under the deliberative

process privilege, information must be “both predecisional and deliberative.” Mapother, 3 F.3d


11

at 1537. A document is pre-decisional if “it was generated before the adoption of an agency

policy.” Coastal States, 617 F.2d at 866. A document is deliberative if “it reflects the give-and-

take of the consultative process.” Id. The U.S. Supreme Court has emphasized that whether a

document is pre-decisional does not depend on the agency’s ability to identify a specific decision

for which the document was prepared. Sears, 421 U.S. at 151 n.18; see also Schell v. HHS, 843

F.2d 933, 941 (6th Cir. 1988) (“When specific advice is provided, . . . it is no less pre-decisional

because it is accepted or rejected in silence, or perhaps simply incorporated into the thinking of

superiors for future use.”). Rather, the deliberative process privilege applies as long as the

document is generated as part of a continuing process of agency decision-making.

Here, the documents for which CDC claimed Exemption 5 protection and withheld in full

or in part include:

draft manuscripts

internal e-mail communication discussing edits to draft manuscripts

internal e-mail communication discussing data underlying manuscripts

internal e-mail communication discussing publication of draft manuscripts

draft correspondence

reviewer comments on draft manuscripts

As discussed in detail below, each category of documents is entitled to the protection of

Exemption 5.

i. The withheld documents were intra-agency

As stated above, the threshold requirement under Exemption 5 is that records be “inter-

agency or intra-agency memorandums.” Judicial Watch, Inc., 90 F. Supp.2d at 13. The withheld

documents fall into four categories: (1) intra-agency documents, (2) documents exchanged


12

between CDC and outside researchers, (3) documents exchanged between CDC and Thomas

Verstraeten, a former CDC employee, and (4) reviewer comments. As to the first category,

records created by a government agency and circulated within that agency manifestly meet this

threshold requirement. See, e.g., Ryan v. U.S. Dep’t of Justice, 617 F.2d 781, 790 (D.C. Cir.

1980).

The remaining categories of documents, those exchanged between defendant and

researchers under a grant, those exchanged between defendant and Thomas Verstraeten, and

reviewer comments, respectively, meet this threshold requirement as well. It is well established

that certain records exchanged between an agency and an outside party can readily meet the

threshold requirements of Exemption 5. As the D.C. Circuit has noted, “Congress apparently did

not intend ‘inter-agency or intra-agency’ to be rigidly exclusive terms.” Ryan, 617 F.2d at 790.

This flexible approach is due largely to the fact that on occasion agencies, in the performance of

their duties, have “a special need for the opinions and recommendations of temporary

consultants.” Soucie v. David, 448 F.2d 1067, 1078 n.44 (D.C. Cir. 1971); see also, e.g., Hoover

v. U.S. Dep’t of the Interior, 611 F.2d 1132, 1138 (5th Cir. 1980); Wu v. Nat’l Endowment for

the Humanities, 460 F.2d 1030, 1032 (5th Cir. 1972). This so-called “consultant corollary”

covers those providing consultant advice regardless of whether the third party has a contract for

services or opinions are rendered on a volunteer basis. See, e.g., Nat’l Inst. of Military Justice v.

DOD, 512 F.3d 677, 681 (D.C. Cir. 2008); Wu, 460 F.2d at 1032.

Researchers collaborating with CDC or working pursuant to a grant, fall within this

category. HHS, in fact, is directed by statute to collaborate with researchers. See 42 U.S.C. §

241(a) (“The Secretary shall conduct in the Service, and encourage, cooperate with, and render

assistance to other appropriate public authorities, scientific institutions, and scientists in the


13

conduct of, and promote the coordination of, research, investigations, experiments,

demonstrations, and studies…”). Because of the consultative role these individuals play, their

deliberative, pre-decisional communications with the CDC are protected by the deliberative

process privilege. See, e.g., Hoover, 611 F.2d 1132, 1138 (appraisal report prepared by an

outside consultant); Wu, 460 F.2d at 1038 (outside experts reviewing grant proposals); Ryan, 617

F.2d at 790 (Senators responding to a questionnaire from the Department of Justice). Outside

reviewers also fall within this category. Formaldehyde Inst. v. HHS, 889 F.2d 1118, 1123-1124

(D.C. Cir. 1989) (holding that letters and comments from outside reviewers may fall within the

purview of exemption 5, even where there is no formal relationship with HHS).

Dr. Thomas Verstraeten falls into this category as well. Dr. Verstraeten is a former CDC

employee. Maloney Decl. ¶ 46. After he left the CDC, Dr. Verstraeten continued to work on

projects that had started during his tenure at CDC. Id. For example, Dr. Verstraeten continued to

work on a manuscript entitled “Safety of Thimerosal-Containing Vaccines: A Two-Phased Study

of Computerized Health Maintenance Organization Databases.” This manuscript was published

in November, 2003, after Dr. Verstraeten left CDC. Dr. Verstreaten continued to work on the

manuscript, even though he was no longer employed by the CDC, but he is listed as a CDC

employee on the manuscript. Id. Dr. Verstraeten’s continued work on the manuscripts that he

began working on during his tenure at CDC establish that he is an outside expert or temporary

consultant for the application of Exemption 5.

To be sure, in Department of the Interior v. Klamath Water Users Protective Ass'n, the

Supreme Court ruled that an outside party could not qualify as a “consultant” under the

Exemption 5 threshold if the outside party was seeking a government benefit at the expense of

other parties. See Klamath, 532 U.S. 1, 12 (2001). Here, however, the researchers and reviewers


14

are not interested parties. The outside parties in this case were simply providing their neutral,

expert advice in order to aid the agency's decisionmaking. Id.; see also Formaldehyde Institute v.

HHS, 889 F.2d 1118, 1123-24 (D.C. Cir. 1989). This is precisely the sort of outside consultant

that has been included under the flexible approach to the Exemption 5 threshold traditionally

taken by courts in this and other circuits in cases such as Ryan, Hoover, Formaldehyde Institute,

and Wu.

ii. The documents were predecisional and deliberative

For documents to be withheld properly pursuant to the deliberative process privilege

under Exemption 5, the communications must be both “predecisional,” (i.e., “antecedent to the

adoption of an agency policy,” Jordan v. United States Dep’t of Justice, 591 F.2d 753, 774

(D.C. Cir. 1978), and “deliberative” (i.e., “recommend[ing] or express[ing] opinions on legal or

policy matters,” Vaughn v. Rosen, 523 F.2d 1136, 1143-44 (D.C. Cir. 1975)). The documents

withheld under Exemption 5 in this case satisfy both of these requirements, as is made clear by

the Vaughn Indexes and declarations.

As this Court has noted, “[d]rafts and comments on drafts are squarely within the scope

of Exemption 5.” Judicial Watch, Inc. v. U.S. Dep't of Commerce, 337 F. Supp. 2d 146, 174

(D.D.C. 2004) (internal citation omitted). In further fleshing out the contours of this privilege,

the D.C. Circuit has explained that “[d]ocuments which are protected by the privilege are those

which would inaccurately reflect or prematurely disclose the views of the agency, suggesting as

agency position that which is as yet only a personal position.” Coastal States Gas Corp., 617

F.2d at 866. Clearly, draft documents -- which by their very nature are preliminary and represent

the authors’ recommendations about what the final document should say (see Maloney Decl. ¶

42) -- meet the standard elucidated in Coastal States and its progeny. See, e.g., City of Va. Beach


15

v. U.S. Dep't of Commerce, 995 F.2d 1247, 1255 (4th Cir. 1993); Town of Norfolk v. U.S. Corps

of Eng’rs, 968 F.2d 1438, 1458 (1st Cir. 1992).

The CDC “must decide whether and to what extent to edit an article, and it assists agency

decisionmakers who are authorized to determine whether and where to publish an article.”

Formaldehyde Inst. v. HHS, 889 F.2d 1118, 1123 (D.C. Cir. 1989). This is a result of HHS’s

statutory mandate to conduct research. As recognized by this court in Formaldehyde Inst. v.

HHS,

Congress has instructed the HHS Secretary to

conduct ... and encourage, cooperate with, and render assistance to other appropriate public authorities, scientific institutions, and scientists in the conduct of, and promote the coordination of, research, investigations, experiments, demonstrations, and studies relating to the causes, diagnosis, treatment, control, and prevention of physical and mental diseases and impairments of man.

42 U.S.C. § 241(a) (Supp. V 1988) and furthermore to ‘collect and make available through publications and other appropriate means, information as to, and the practical application of, such research and other activities.’ 42 U.S.C. § 241(a)(1) (1982). Thus, Congress has directed HHS to make precisely the kind of "deliberative" decision HHS made as a result of a process that involved HHS' receipt of the Review Letter.

Id. at 1124. It follows then, that the process leading up to a decision on whether to publish a

manuscript is both predecisional and deliberative.

As described in detail in the Vaughn index attached as Exhibit A to the Maloney

Declaration, each record withheld pursuant to the deliberative process privilege is a draft

manuscript, draft correspondence, reviewer comments, or deliberative communication generated

in the course of internal Agency discussions regarding publication of manuscripts. Maloney

Decl. ¶¶ 22 & 41. The evolving iterations of documents and correspondence contain the current


16

opinions of the drafters; they do not reflect the settled decisions of the Agency as to what

information should be included in the final documents and are thus predecisional. See Goodrich

Corp. v. E.P.A., 593 F. Supp. 2d 184, 189 (D.D.C. 2009) (“As a general matter, ‘drafts’ of

documents are exempt from disclosure under the deliberative process privilege.”).

Comments submitted by outside reviewers are also pre-decisional and deliberative.

Comments submitted by reviewers “are used by the CDC to determine whether to seek

publication of a manuscript and provide guidance with respect to revision of the manuscript.”

Maloney Decl. ¶42. These comments do not reflect the settled decisions of the Agency as to

what information should be included in the final documents and are thus predecisional and

deliberative. See Formaldehyde Inst. v. HHS, 889 F.2d 1118, 1124 (D.C. Cir. 1989) (holding

that outside reviewer comments on a draft manuscript are protected by the deliberative process

privilege).

C. HHS Properly Asserted Exemption 6

FOIA Exemption 6 protects from disclosure “personnel and medical files and similar files

the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.” 5

U.S.C. § 552(b)(6). The term “similar files” includes any “‘Government records on an

individual which can be identified as applying to that individual.’” U.S. Dep’t of State v.

Washington Post Co., 456 U.S. 595, 602 (1982) (quoting H.R. Rep. No. 1497, 89th Cong., 2nd

Sess., 11 (1966), U.S.C.C.A.N. 1966, p. 2428). Thus, Exemption 6 applies whenever disclosure

would constitute a clearly unwarranted invasion of personal privacy. Id. In assessing the

applicability of Exemption 6, courts weigh the privacy interests in nondisclosure against the

public interests in disclosure. See Beck v. Dep’t of Justice, 997 F.2d 1489, 1491 (D.C. Cir.

1993). The public interest served by the release of private information is “the preservation of


17

‘the citizens’ right to be informed about what their government is up to.’” Beck v. Dep’t of

Justice, 997 F.2d 1489, 1492 (D.C. Cir. 1993) (quoting Dep’t of Justice v. Reporters Comm. for

Freedom of the Press, 489 U.S. 749, 773 (1989)). “Information that ‘reveals little or nothing

about an agency’s own conduct’ does not further the statutory purpose.” Id.

Here, CDC invoked Exemption 6 to protect contact information for CDC employees and

a former CDC employee, and third parties whose personal information was reflected in the

responsive documents. See Maloney Decl. ¶¶ 25 & 48. Specifically, HHS invoked Exemption 6

to protect portions of documents containing contact information (e-mail addresses, telephone, fax

contact information) of individuals. Id. HHS determined that release of contact information

pertaining to a former employee and outside individuals would not substantially further any

public interest, as it would reveal little about the Agency’s conduct. See Maloney Decl. ¶¶2 6 &

49. Indeed, courts have held that disclosure of contact information for private individuals would

not shed any light on the workings of an agency. Gov’t Accountability Project v. United States

Dep’t of State, 699 F. Supp. 2d 97, 106 (D.D.C. 2010) (internal citations omitted) (“Here, the

private individuals mentioned in these records have a clear privacy interest in avoiding the

disclosure of their personal email addresses. Furthermore, releasing their email addresses serves

no public interest because these email addresses would not reveal ‘what the government is up

to.’”). CDC also redacted certain personal discussions found in the responsive emails. These

discussions include topics such as an individual’s personal life or travel plans. This information

would shed no light on the workings of an agency and the release of these discussions would be

an unwarranted invasion of personal privacy. Thus, the redactions of contact information were

properly applied pursuant to Exemption 6.

D. HHS Properly Withheld Documents Protect by the Copyright Act


18

CDC withheld four documents protected by the Copyright Act of 1976, 17 U.S.C. §§

101, et seq., which essentially grants the holder of a copyright an exclusive right to reproduce

and distribute copies of his work. See 17 U.S.C. § 106. Agencies can use Exemption 4, 5 U.S.C.

§ 552(b)(4), to protect information protected by the Copyright Act. To qualify for protection

under Exemption 4, the requested records must consist of: (1) commercial or financial

information, that is (2) obtained from a person,3 and (3) is privileged or confidential. See, e.g., 45

C.F.R. § 5.65; United Technologies Corp. v. United States Dep’t of Defense, 601 F.3d 557, 563

(D.C. Cir. 2010); Gulf & Western Indus., Inc. v. United States, 615 F.2d 527, 529 (D.C. Cir.

1980).

With regard to the first part of the test, courts have broadly construed the term

“commercial” as used in Exemption 4. See e.g., Public Citizen Health Research Group v. FDA,

704 F.2d 1280, 1290 (D.C. Cir. 1983) (“Public Citizen”); accord Baker & Hostetler LLP v. U.S.

Dep’t of Commerce, 473 F.3d 312, 319-20 (D.C. Cir. 2006). In Public Citizen, the D.C. Circuit

held that the term “commercial” should be given its “ordinary” meaning, and specifically

rejected the view that in order to qualify for Exemption 4 protection the information had to

“reveal basic commercial operations.” 704 F.2d at 1290. Instead, the Court held that records are

commercial for Exemption 4 purposes if the submitter has a “commercial interest” in them. Id. at

1290; see also, e.g., American Airlines v. National Mediation Bd., 588 F.2d 863, 870 (2d Cir.

1978) (“‘commercial’ surely means [information] ... dealing with commerce”). Authors certainly

have a commercial interest in their copyrighted material.

3 The phrase “obtained from a person” naturally includes information obtained from corporations and a wide range of other entities, as well. See 5 U.S.C. § 551(2) (“‘person’ includes an individual, partnership, corporation, association, or public or private organization other than an agency”); 45 C.F.R. § 5.65(b)(2); Nadler v. FDIC, 92 F.3d 93, 95 (2d Cir. 1996); Allnet Communications Servs v. FCC, 800 F. Supp. 984, 988 (D.D.C. 1992), aff’d No. 92-5351 (D.C. Cir. May 2, 1994).


19

The copyrighted materials also qualify as “confidential” under the tests announced by the

D.C. Circuit for FOIA Exemption 4. In National Parks & Conservation Ass’n v. Morton, 498

F.2d 765 (D.C. Cir. 1974) (“National Parks”), the Court of Appeals adopted a two-pronged test

for determining whether commercial or financial information is “confidential” under Exemption

4:

[C]ommercial or financial matter is “confidential” for purposes of the exemption if disclosure of the information is likely to have either of the following effects: (1) to impair the Government’s ability to obtain necessary information in the future; or (2) to cause substantial harm to the competitive position of the person from whom the information was obtained.

Id. at 770.

In its subsequent en banc decision in Critical Mass II, the D.C. Circuit reaffirmed the

two-pronged test in National Parks, but confined it to the category of cases to which it was first

applied, namely, those in which a FOIA request is made for financial or commercial information

a person was obliged to furnish the Government. Critical Mass Energy Project v. Nuclear

Regulatory Comm’n, 975 F.2d 871, 872 (D.C. Cir. 1992). The Court of Appeals in Critical Mass

II also recognized another basis on which materials may be withheld under Exemption 4:

We conclude that any financial or commercial information provided to the Government on a voluntary basis is “confidential” for the purposes of Exemption 4 if it is of the kind that would customarily not be released to the public by the person from whom it was obtained.

Id. at 879. In doing so, the Court applied a “categorical” approach to protect voluntarily

submitted information that is intended to greatly simplify the application of Exemption 4 in a

significant number of cases. Id. at 879.

Thus, the rule in this Circuit is that confidential commercial or financial information

obtained from a person can be withheld under Exemption 4 for any one of the following reasons:

(1) if it is voluntarily provided by the submitter and is not of the type customarily released to the


20

public by the submitter; or (2) if it is compelled to be provided to the Government, it can be

withheld as exempt if its disclosure would (a) impair the Government's ability to obtain the

necessary information in the future, (b) imperil the governmental interest in administrative

efficiency, or (c) cause substantial harm to the competitive position of the person from whom the

information was obtained. Critical Mass II, 975 F.2d at 878-79.

Copyrighted materials, by their very nature, are not customarily released to the public

without charge or permission from the copyright holder. Maloney Decl. ¶ 50. Indeed, “there is a

presumption of irreparable harm when a copyright is infringed.” Gilmore v. United States DOE,

4 F. Supp. 2d 912, 923 n.3 (N.D. Cal. 1998) (citing Cadence Design Sys., Inc. v. Avant! Corp.,

125 F.3d 824, 827-28 (9th Cir. 1997)). Because the copyrighted materials that were voluntarily

submitted are confidential and would cause harm if released, CDC properly withheld the

copyrighted materials.

E. HHS Complied With FOIA’s Segregability Requirement

Under the FOIA, if a record contains information exempt from disclosure, any

“reasonably segregable,” non-exempt information must be disclosed after redaction of the

exempt information. 5 U.S.C. § 552(b). Non-exempt portions of records need not be disclosed

if they are “inextricably intertwined with exempt portions.” Mead Data Cent., Inc. v. Dep’t of

the Air Force, 566 F.2d 242, 260 (D.C. Cir. 1977). To establish that all reasonably segregable,

non-exempt information has been disclosed, an agency need only show “with ‘reasonable

specificity’” that the information it has withheld cannot be further segregated. Armstrong v.

Executive Office of the President, 97 F.3d 575, 578-79 (D.C. Cir. 1996); Canning v. Dep’t of

Justice, 567 F. Supp. 2d 104, 110 (D.D.C. 2008).


21

Where non-exempt information could be segregated from exempt information, CDC

segregated and disclosed the non-exempt information. Maloney Decl. ¶ 27 & 51. CDC has

established, with reasonable specificity, that responsive documents were redacted in part or

withheld in full after a line-by-line review and determination that there were no reasonably

segregable portions of documents appropriate for release. Id. CDC therefore complied with its

duty to segregate exempt from non-exempt information.

CONCLUSION

For the reasons set forth above, Defendants respectfully request that this Court grant their

motion for summary judgment as to all claims in this case.

Respectfully submitted,

RONALD C. MACHEN Jr. United States Attorney RUDOLPH CONTRERAS, Chief, Civil Division By: /s/ Harry B. Roback HARRY B. ROBACK, D.C. Bar # 485145 Assistant United States Attorney United States Attorneys Office 555 4th Street, N.W. Washington, D.C. 20530 Tel: 202-616-5309 [email protected] November 4, 2011 Counsel for Defendants


Msj

Documents

autistic spectrum

critical mass

add brent

negative ecological

andrews study

considered

columbia brian

national immunization