• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

About FDA

  • Print
  • Share
  • E-mail

MOU 225-04-4007

Memorandum of Understanding

Between
The Federal Bureau of Investigation 

and

 

The United States Food and Drug Administration

 

GENERAL PROVISIONS

1. PURPOSE.

This memorandum of agreement (MOA) establishes the process that the United Sates Food & Drug administration, Forensic Chemistry Center (FDA-FCC) and the Federal Bureau of Investigation (FBI) have mutually agreed to use to support specific tasks to be performed by each agency to execute U.S. Government (USG) commitments and obligations and necessary mission support. This MOA establishes the general policies and procedures that will govern administrative, logistical, and operational support to FBI missions including cost reimbursable activities.

 

2. AUTHORITY.

The authority to establish this support agreement is contained in the following references:

a. 10 U.S.C. 371 – 382.

b. 18 U.S.C. 229E.

c. 28 U.S.C. 533.

d. 42 U.S.C. 3771.

e. Presidential Decision Directive 39 (PDD-39), titled: U.S. Policy on Counterterrorism.

f. PDD-62, titled: Combating Terrorism.

g. PDD-63, titled: Critical Infrastructure Protection.

h. NSPD-17/HSPD-4: titled: National Strategy to Combat Weapons of Mass Destruction.

i. HSPD-5, titled: Management of Domestic Incidents.

 

3. SCOPE.

This MOA defines the relationship between FDA-FCC and the FBI Laboratory in issues of direct analytical services, co-activation/co-development, expert advice and counsel, work space allocation, and research and development.

a. General. This MOA establishes a relationship between FDA-FCC and the FBI. Contingent upon agreement of the FDA-FCC Director, FDA-FCC will provide scientific consultation and analytical services concerning the forensic examination of samples within respective areas of expertise. FDA-FCC will coordinate with the FBI to develop and manage specialized equipment, laboratory space, analytical protocols, and appropriately trained personnel.

b. The FBI will provide funding for all work as stated in paragraph 5.

c. The FBI, or its designated agent, will retrieve, package, transport and deliver all unknown materials intended for assessment or analysis by FDA-FCC, specifically. The FBI will additionally provide documentation of all field collection, processing and screening efforts associated with the materials presented to FDA-FCC for examination. The evidence or analyzed materials will be returned to the FBI for disposition, or disposed of at the cost of the FBI. If required, FDA-FCC will store or dispose of evidence or analyzed material at the direction of the FBI. Any extra expense incurred for storage and disposal will be paid by the FBI.

d. With the approval of the FCC Director, the FDA-FCC will provide analysis of FBI samples.

e. With the approval of the FCC Director, FDA-FCC will provide expert technical advice and counsel as appropriate regarding subjects of mutual interest, as well as analytical characterization and/or forensic examination of submitted specimens, along with eventual courtroom testimony if required. Additionally, calling upon the resources of FDA-FCC as a whole, FDA-FCC will organize and coordinate training courses for Bureau personnel in particular areas upon request by the Chemical Biological Sciences Unit (CBSU) or the Hazardous Materials Response Unit (HMRU).

f. Possible Work Space Collocation and Collaborative Work: Consistent with personnel security requirements and good scientific practice, the parties may seek opportunities for project-specific collocation of personnel assets for professional development and training.

g. Field Exercises and Training: Whenever feasible, and consistent with the security requirements, the parties will seek opportunities for mutually beneficial technology transfers and training.

h. All work performed by FDA-FCC shall meet or exceed the quality assurance standards associated with the Bureau laboratory's accreditation.

i. FDA-FCC will immediately notify the FBI if any work being undertaken for the Bureau at FDA-FCC is negatively impacted by other work on-going at FDA-FCC for other customers or programs.

j. Reporting of the status, preliminary results, and/or results of the examination of FBI samples will be exclusively to the Bureau. Only those FDA-FCC staff members having a need to know the details of the examinations conducted will be privy to same.

k. Inventions and Licensing: Activities conducted to carry out this MOA may result in products or processes that are patentable or otherwise proprietary. The organization whose work results in the invention shall disclose the invention to the other organization and then prepare, file, and prosecute patent applications. If the protection is granted, the inventing organization will manage the invention in accordance with its rules and regulations. Inventions resulting from joint research and development by both FDA-FCC and FBI employees shall be handled as jointly agreed to at the time of the disclosure.

 

4. BACKGROUND.

a. The FBI Laboratory's CBSU has the mission to conduct and/or direct the forensic examination of hazardous chemical, biological, and radiological/nuclear materials, and all related evidence. The FBI Laboratory traditionally has relied upon the assistance provided by the Department of Defense (DoD) and the Department of Energy (DoE) when responding to cases in which Weapons of Mass Destruction (WMD) are implicated. This MOA expands the scope of scientific resources within the U.S. Government (USG) that will be available to respond to acts of terrorism involving hazardous chemicals.

b. The FDA's Forensic Chemistry Center is charged with developing and maintaining state-of-the-art expertise in forensic analysis in support of FDA's mission to protect public health and safeguard the Nation's food and drug supply. This includes the development and implementation of new tools and analytical techniques to detect, identify, and fingerprint toxic chemicals in foods and drugs. The FCC is responsible for providing rapid response and specialized analytical services for activities related to product tampering, chemical terrorism, and counterfeit products. The FCC provides the analytical support and scientific expertise for FDA's Office of Criminal Investigations and upon request provides assistance to other Federal, State and Local agencies. The FCC is staffed with scientists whose training, background, and experience make them uniquely qualified to deal with foods and drugs contaminated with toxic chemicals.

 

5. FUNDING AND REIMBURSEMENT:

This Agreement is neither an obligation nor a commitment of funds, nor is it basis for a transfer of funds, but rather it is a statement of understanding between the parties. Expenditures by each party are subject to the parties' budgetary processes and to the availability of funds and resources pursuant to applicable laws, regulations, and policies. Funds provided by the FBI shall be considered obligated upon FDA-FCC acceptance of the funding authorization. Established FDA-FCC accounting procedures will be used for recording costs.

a. The FBI will fund FDA-FCC on an annual basis for recurring services under this agreement, including but not limited to: training deployments, FBI annual training at FDA-FCC, exercises, specialized training, analytical support and sample analysis. Additional work (within the scope, but in addition to that listed above, such as additional unforeseen analytical support and sample analysis) will be coordinated with FDA-FCC and will be funded on a reimbursable basis.

 

All funding documents must be provided to FDA-FCC in advance of initiation of work, and should be addressed to:

Donna J. Riley
Administrative Officer
U.S. FDA
Forensic Chemistry Center
6751 Steger Dr.
Cincinnati, Ohio 45237

 

b. The use of facilities and equipment and required facility upgrades (specifically the FBI's requirement for a facility upgrade to handle unknown samples) will be negotiated separately. The FBI will provide funding in advance of any action by FDA-FCC.

c. FDA-FCC will bill the FBI on a monthly basis for longer-term projects or per submission on shorter-term projects for all work performed. FDA-FCC will provide special reports, in a format designated by the FBI, on a quarterly basis for longer-term projects and per submission on shorter-term projects.

It is expected that the FBI's contracting Officer will send to the FDA-FCC a U.S. Department of Justice Reimbursement Agreement (Form DOJ-216) for reimbursement. A Reimbursement Agreement, DOJ-216, with funding will be issued for every task that is agreed to by the parties.

The FDA-FCC will sign and return the DOJ-216 as acceptance and will send a copy to the FBI's Contracting Officer. The FDA-FCC then will be able to submit charges to the Treasury in accordance with the U.S. Treasury's automated IntraBGovernmental Payment and Collection System (IPAC). Failure to provide this information on any IPAC billing will result in the IMMEDIATE charge back of the funds taken. Per the Business Rules for Intragovernmental Transactions issued by OMB on 10/04/02, the FDA-FCC will also include all other "Data Elements for Intragovernmental Bills" (e.g., selling agency's DUNS number) on each IPAC transaction. The FDA-FCC will provide reports to the FBI Contracting Officer, coinciding with each IPAC submitted, that will detail the items and/or services provided during the time period covered by the IPAC.

 

6. GUIDELINES, PROCEDURES, AND RESPONSIBILITIES.

a. A request for activation/deployment of appropriately trained FDA-FCC personnel to support CBSU for operational response to Domestic Terrorism or Special Event Security Protection, will originate from the Chief of the CBSU, and will be directed to the FDA-FCC Director for approval.

b. The FBI, or its designated agent, will retrieve, package, transport and deliver all unknown designated material to FDA-FCC. [SEE ABOVE].

c. FDA-FCC will identify and maintain a roster of technical experts for the purpose of providing expert opinions, technical assessments, and testimony as required, for missions under this MOA.

With the approval of the FCC Director these technical experts will be deployed CONUS subject to terms in separate operations plan (TBD).

d. All requests for FDA-FCC support for out of the continental united states (OCONUS) deployment will be made through the FDA-FCC Director FDA-FCC personnel traveling OCONUS under this MOA will be at all times identified as civilian personnel attached to the FBI deployment team.

 

7. POTENTIAL PERSONNEL ASSIGNMENTS.

a. FDA-FCC will provide certification to the FBI that each person nominated for a potential assignment (NTE one year) to the FBI Laboratory has a current SECRET clearance and the date of the latest background investigation. If higher clearances are required for specific assignments taken on behalf of the FBI than currently held by candidates, all costs associated with conducting or updating a candidate's background investigation will be borne by the FBI. Candidates with existing higher clearances may also be considered.

b. FDA-FCC will ensure that FDA personnel temporarily assigned to the FBI Laboratory, if any, are advised that throughout the period of an individual's assignment, he remains an FDA-FCC employee for all purposes during the period of this temporary assignment, including such matters as compensation, retirement, disability, and health benefits. For those employees during this period, the FBI will perform the timekeeping function and provide performance appraisal input. Additionally, any compensatory time earned during this assignment will be taken during the same assignment period. FDA-FCC will further ensure that their personnel are advised that they remain individually responsible for their personal insurance programs and that no insurance benefits are payable to them or their beneficiaries by the FBI.

c. To preclude inappropriate disclosure of information, each person temporarily assigned to the FBI under the terms of this MOA may be required to sign a General Nondisclosure Agreement and a Classified Information Nondisclosure Agreement (SF-312), as well as the new FBI form FD-868 (Non-disclosure Agreement for Task Force members/contractors).

d. Information generated for the FBI by FDA-FCC and by the FBI should be considered Law Enforcement Sensitive and exempt from the Freedom of Information Act.

 

8. CHANGES, REVIEWS, AND REVISIONS:

a. Cyclical reviews:

(1) This agreement will be reviewed upon the first anniversary of its effective date to determine if changes or revisions are required. This review will be initiated by the FBI within 90 days of the anniversary date. Revisions require bilateral agreement.

(2) After the first anniversary review, this agreement will be reviewed every three years. These reviews will be initiated by the FBI within 90 days of the anniversary date. Revisions require bilateral agreement.

b. Out-of-cycle review: This agreement may be reviewed any time changes in mission or resources of the parties may adversely impact performance of this agreement. These reviews may be initiated by either party as required. Revisions may be suggested by either of the parties during any of the review processes, or at any time that a revision is necessary. Revisions require bilateral agreement.

c. All parties to the MOA shall not release information derived from the FBI to a third party without approval of the FBI. Reports of analysis released to the FBI by FDA-FCC can be used by the FBI for official use; however, in no case will the FBI attribute results to FDA-FCC without specific authorization of FDA-FCC. FDA-FCC technical reports, not paid for by the FBI, that are released to the FBI for information will be treated by the FBI in accordance with FDA-FCC rules for classification and distribution.

 

9. ADMINISTRATION.

The Designated FDA-FCC representative, and the Chief of the Scientific Analysis Section (SAS), FBI, will appoint staff elements to be responsible for implementation and administration of this agreement.

 

a. For the FDA-FCC, the MOA will be implemented and administered by the FCC Director. The point of contact (POC) for the FDA-FCC will be:

Fred Fricke
Director
Food & Drug Administration
Forensic Chemistry Center
6751 Steger Dr.
Cincinnati, Ohio 45237
(513) 679-2700

 

b. For the FBI, this MOA will be implemented and administered by the CBSU. POC for the FBI will be:

Supervisory Special Agent David L. Wilson
Unit Chief, CBSU
FBI Laboratory
Quantico, VA
(703) 632-7766

 

c. For the FBI, the Finance Division POC for this MOA will be:

Mr. Ron Chiodi
Unit Chief, Construction and General Contracts Unit
(202) 324-0560

 

d. For FDA-FCC, the financial POC for this MOA will be:

Donna J. Riley
Administrative Officer
Forensic Chemistry Center
(513) 679-2700 x 190

 

e. Patents and Technical Data

Appropriate patent and other intellectual property provisions shall be included in interagency agreements and any other agreements entered into by the signing parties in order to implement this MOA. FDA-FCC patent and intellectual property policies shall apply to any such work performed by contactors (including any subcontractor) which is funded in whole or in part by FDA-FCC. Rights to inventions made by U.S. Government employees shall be determined by the employing agency.

 

f. Public Information-Coordination

Subject to the Freedom of Information Act (5 U.S.C. 552), requests for disclosure of information to the public regarding projects and programs referenced to in this MOA shall be forwarded to the FBI. Release of said information will be made in coordination with the FBI. The release of information for the purpose of publication in any professional, scientific or technical journals, newspapers, newsletters or other related electronic media will be similarly coordinated.

All media release and statements will be mutually agreed upon and jointly handled according to FBI and FDA-FCC guidelines. The parties agree that the information will only be disseminated to the media in accordance with the terms of this MOA.

This MOA remains the property of the FBI and FDA-FCC. Third party requests for the MOA, including discovery requests and requests pursuant to the Freedom of Information Act for the agreement itself or any work done pursuant to it, will be coordinated with the FBI.

 

g. Procurement

Subject to the statutory requirements applicable to the requesting agency, procurement shall be conducted in a manner consistent with the legal authority, responsibilities, and policies of the procuring agency.

 

10. CIVIL LIABILITY OF THE PARTIES

Each party agrees that should a claim arise under the terms and conditions of the Federal Tort Claims Act (FTCA), Title 28, United States Code, Sections 1346 and 2671 et seq., for the negligent or wrongful acts or omissions by its respective federal employee(s), that party shall be responsible for the investigation and disposition of said claim. The parties further agree that the FBI shall assume primary responsibility for the investigation and disposition of an administrative claim arising out of a criminal investigation prompted by this MOU and involving the FBI and FDA-FCC. For all other administrative claims involving both federal parties and arising out of an activity conducted pursuant to this MOU, the federal entity responsible for supervising the activity which resulted in the administrative claim shall assume primary responsibility for the investigation and disposition of the claim.

 

Each federal party agrees to notify the other federal party of any administrative claim arising out of an activity conducted pursuant to this MOU.

Nothing in this section prevents any party from conducting an independent administrative review of the incident giving rise to the claim; however, final disposition of the claim will be handled as provided in this Paragraph. Nothing in this section should be construed as supplanting any applicable statute, rule or regulation.

 

11. RESOLUTION OF CONFLICTS.

Nothing in this MOA shall take precedence or negate in any way the policy, directives, and procedures of the respective signatory agencies. Conflicts between this document and any other agency guidance shall be referred to the respective POC for resolution. If resolution cannot be satisfactorily achieved at this level, the responsible POCs shall forward the problem to the signatories of this MOA through their respective channels.

 

12. EFFECTIVE DATE TERM AND TERMINATION.

a. This MOA will have a term of 3 years, which can be extended for 3 years with bilateral agreement.

b. If termination of the MOA is desired by one agency, the termination agency shall notify the other agency through official channels, in writing, at the earliest possible time, but no later than 90 days prior to the desired termination date. The disposition of work in process, if any, at the time of the termination notification, shall be handled on a bilateral basis. In the event of termination, the requesting agency shall be liable for any costs associated with the termination.

c. This MOA shall become effective on the latest date of approval and signature by FDA-FCC and the Deputy Assistant Director, FBI Laboratory. It shall remain in effect until completion or specifically canceled or suspended by either agency.

Approved and Accepted
for the Federal Bureau of Investigation

Signed by: Dwight E. Adams, Ph.D.
Director, FBI Laboratory

Date: November 3, 2004

Approved and Accepted
for the Federal Bureau of Investigation

Signed by: Anthony J. Baumann
Chief Contracting Officer
FBI Finance Division

Date: December 22, 2004

Approved and Accepted
for the Food and Drug Administration

Signed by: John M. Taylor
Associate Commissioner for Regulatory Affairs

Date: November 3, 2004