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MEMORANDUM OF UNDERSTANDING (MOU) BETWEEN THE

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)

ANDTHE UNITED STATES DEPARTMENT OF AGRICULTURE (USDA)

ANIMAL AND PLANT HEALTH.INSPECTION SERVICES (APHIS) ANDTHE

UNITED STATES DEPARTMENT OF ENERGY

ARTICLE I-BACKGROUND

The Public Health Secur(ty and Bioterrorism Preparedness and Response Act of 2002, (Public Law 107-188) (the Act) requires the United States Department of Health and Human Services (HHS) and the United States Department of Agriculture (USDA) to regulate the possession, use, and transfer of biological agents and toxins that have the potential to pose a severe threat to public health and safety, animal or plant health, or animal or plant products. These biological agents and toxins are referred to as select agents. In accordance with the Act, HHS and USDA promulgated the Select Agent regulations found in 42 C.F.R. Part 73, 7 C.F.R. Part 331, and 9 C.F.R. Part 121. The Centers for Disease Control and Prevention (CDC), along with USDA's Animal and Plant Health Inspection Service (APHIS), are charged with implementing these regulations. · ·

CDC and APHIS maintain a database of all registered entities in the United States that possess, use, or transfer select agents. CDC and APHIS collect information from registered and non-registered entities in the course of implementing the Select Agent regulations. The collection of information involves periodic visits to registered entities to confirm the information provided by the registered entities and to ensure compliance by the entity with the Select Agent regulations. Although unclassified, CDC and APHIS consider the information contained in the database and any information collected from the entity either through receipt of the information or visits to the entities to be sensitive such that it requires protection from unauthorized disclosure and special handling safeguards. CDC has determined that the unauthorized disclosure of this sensitive information could adversely impact the ability of the United States to protect critical systems, facilities, stockpiles, and other assets.

The United States Department of Energy (DOE) is responsible for providing compliance support and oversight for registered DOE entities and select agent activities conducted or sponsored by DOE.

To reduce the burden on registered entities, CDC and APHIS have entered into this MOU with DOE to share information as is agreed by all parties and to protect the information from unauthorized disclosure. Further CDC, APHIS, and DOE agree to coordinate the site visits to facilities owned and operated by DOE or operated for DOE by DOE

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contractors on DOE sites (hereafter, "DOE facilities"), to share the information collected during these site visits, and to protect the information from the unauthorized disclosure of the information.

ARTICLE 2-PURPOSE

To reduce the burden on registered entities at DOE facilities and facilitate the coordination of oversight efforts, CDC, APHIS, and DOE have agreed:

• to share the results of inspections and other site visits (of or concerning) registered entities at DOE facilities, as provided for in this MOU;

• to protect the information from unauthorized disclosure; and • to coordinate inspections and other site visits to registered entities at DOE

facilities.

ARTICLE 3- TERMS

The following terms as used in this MOU mean:

"Select agents and toxins": Those biological agents and toxins that have been designated by regulation by either HHS and/or USDA as select agents and toxins in 42 C.F.R. §§ 73.3, 73.4; 9 C.F.R. §§ 121.3, 121.4; or 7 C.F.R. § 331.3.

"Registered entity": Any government agency (Federal, State, or local), academic institution, corporation, company, partnership, society, association, firm, sole proprietorship, or other legal entity that are registered with APHIS or CDC to possess, use, or transfer select agents.

"Scheduled routine visit": An inspection conducted by APHIS/CDC to verify that a registered entity meets the regulatory requirements outlined in the Select Agent Regulations, or may be an inspection by DOE to verify ifthe registered entity meets the requirements outlined in 10 C.F.R. Part 851, Worker Safety and Health Program.

ARTICLE 4 - AUTHORITIES

APHIS - Subtitle B of Title II of the Public Health Security and Bioterrorism Preparedness and Response Act of2002 (P.L. 107-188, June 12, 2002). This subtitle may be referred to as the "Agricultural Bioterrorism Protection Act of 2002" (7 U.S.C. § 8401).

CDC - Subtitle A of Title II of the Public Health Security and Bioterrorism Preparedness and Response Act of2002 (P.L. 107-188, June 12, 2002). (42 U.S.C. § 262a).

DOE - Atomic Energy Act of 1954, as amended, codified at 42 U.S.C. §§ 2011-2286i; Energy Reorganization Act of 1974, as amended, codified at 42 U.S.C. §§ 5801-5891;

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Department of Energy Organization Act, codified at 42 U.S.C. §§ 7101-7352; Section 646 of the Department of Energy Organization Act (Pub. L. 95-91, as amended; 42 u.s.c. § 7256).

ARTICLE 5 - INDIVIDUAL AGENCY RESPONSIBILITES

The DOE, CDC and APHIS agree to designate in writing authorized representatives who shall be responsible for collaboratively administering the activities conducted under this MOU.

The DOE agrees to:

1. Designate in writing an individual to act as a point of contact with CDC and APHIS to receive inspection information and to address logistical issues associated with receipt of inspection information.

2. Ensure the protection of the information provided to DOE by CDC or APHIS from unauthorized access or release, in accordance with applicable CDC and APHIS policies and guidance provided to DOE.

3. Facilitate oversight coordination by sharing any inspection reports and related documentation from DOE oversight ofregistered entities at DOE facilities, upon request by CDC or APHIS.

4. Facilitate inspection coordination by notifying the CDC and APHIS of any plans to conduct a scheduled routine visit related to select agent and toxin compliance of a registered entity, or entity to be registered under the Select Agent regulations, at least 30 calendar days in advance of such visit. The notification should include the purpose of the visit and the individuals who will be conducting the visit. Further, to notify the CDC and APHIS of any plans to conduct a non-routine site visit to a DOE facility related to select agent and toxin compliance as soon as plans are in place. The notification should include the name of the entity, purpose of the visit, and the individuals conducting the visit.

5. To the extent possible and in the spirit of unity and cooperation, conduct joint site inspections with CDC, APHIS of entities registered to possess select agents and toxins at DOE facilities, collaborate on the execution of inspections, and forge effective inspection team partnerships.

The CDC and APHIS agree to:

1. Designate in writing individuals to act as points of contact with the DOE to obtain the information on registered entities at DOE facilities to address logistical issues associated with receipt of this information.

2. Within the resources and authority of CDC and APHIS, assist the DOE in the conducting of a site visit to a registered entity at a DOE facility.

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3. Ensure the protection of the information provided to CDC or APHIS from unauthorized access or release, in accordance with DOE policies and guidance provided to the CDC and APHIS.

4. Facilitate oversight coordination by sharing any written inspection reports related to registered entities at DOE facilities (i.e., initial observations and close out report). Upon request by the DOE, share other inspection-related data (e.g., registered entities responses, correspondence with registered entities, and checklists).

5. Facilitate inspection coordination by notifying the DOE of any plans to conduct a site visit to registered entities at DOE facilities at least 30 calendar days in advance of such visit. The notification should include the purpose of the visit, and the individuals who will be conducting the visit.

6. Notify the DOE of any plans by CDC or APHIS to conduct a non-routine registered entity site visit at a DOE facility. The notification should include the name of the registered entity, purpose of the visit and the individuals conducting the visit.

7. To the extent possible and in the spirit of unity and cooperation, conduct joint inspections with DOE of registered entities at DOE facilities, collaborate on the execution of inspections, and forge effective inspection team partnerships.

ARTICLE 6- STATEMENT OF NO FINANCIAL OBLIGATION

Signature of this MOU does not constitute a financial obligation on the signature parties. Each signatory party is to use and manage its own funds in carrying out the purpose of this MOU. Transfers of funds or items of value are not authorized under this MOU.

ARTICLE 7 - LIMITIA TIONS OF COMMITMENT

This MOU and any continuation thereof shall be contingent upon the availability of funds appropriated by the Congress of the United States. It is understood and agreed that any monies allocated for purposes covered by this MOU shall be expended in accordance with its terms and the manner prescribed by the fiscal regulations and/or administrative policies of the party making the funds available. If fiscal resources are to transfer, a separate agreement must be developed by the parties.

ARTICLE 8 - AMENDMENTS

This MOU may be amended in writing at any time by mutual agreement of all the parties.

ARTICLE 9 - THIRD PARTY RIGHTS

This MOU is not intended, and should not be construed, to create any right or benefit, substantive or procedural, enforceable at law or otherwise against any of the agencies,

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their parent agencies, the United States, or the officers, employees, agents, or other associated personnel thereof. The agencies will seek to resolve any disputes regarding this MOU by mutual consultation.

ARTICLE 10 - TERMINATION

This MOU may be terminated upon 60 days' written notice by one of the agencies to the other agencies.

ARTICLE 11 - EFFECTIVE DATE AND DURATION

The MOU will become effective upon date of final signature and will remain in effect for 5 years from the date of the final signature.

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