PARTNERSHIP AGREEMENT BETWEEN U.S FOOD AND DRUG ADMINISTRATION AND THE ALASKA DEPARTMENT OF ENVIRONMENTAL CONSERVATION
The purpose of this document is to establish a formal partnership agreement which will coordinate and expand the food protection efforts between the Alaska Department of Environmental Conservation (AK DEC) and the U.S. Food and Drug Administration (FDA). This agreement is to loan a Portable Gamma-ray Analysis System to AK DEC allowing the state radioanalytical capacity and expertise, emergency response capability and provide continued monitoring of Alaskan Coastal water finfish for radionuclides in response to the Fukushima emergency. AK DEC will collect and analyze the samples, providing FDA with the analytical results. FDA will return the final report of analytical results to AK DEC.
II. DURATION OF AGREEMENT
This agreement covers a period of one year from the date of signature. This time frame will give all parties sufficient time to measure the program outcomes that have resulted from the partnership agreement, modify if warranted, and renew with consent of the partners. Review of the PA and goals will be conducted annually, face to face preferably. This PA maybe amended or modified by mutual consent of all parties. Any partner on their imitative may submit a proposed amendment or modification in writing for all parties to review and agree upon. Modifications and amendments will be tracked and documented during the annual review and maintained for historical purposes. This Partnership Agreement is effective upon signing and shall remain in effect until termination by any partner upon thirty (30) day advance written notice to the other partners.
III. DEFINITIONS AND ACRONYMS
AK DEC – Alaska Department of Environmental Conservation
AK DEC EHL – Alaska Department of Environmental Conservation Environmental Health Laboratory
C.F.R. – Code of Federal Regulations
DIDP – Division of Information and Disclosure Policy FDA – U.S. Food and Drug Administration
FACTS – Field Accomplishments and Compliance Tracking System IFSS – Integrated Food Safety System
ORA/OHAFO/HAFW6 (HAFW6) – Office of Human and Animal Food Operations West, Division 6
ORA/ORS/WEAC (WEAC) – Office of Regulatory Affairs, Office of Regulatory Science, Winchester Engineering Analytical Center
ORA – Office of Regulatory Affairs
ORA/OP/DI – Office of Regulatory Affairs, Office of Partnerships, Division of Integration
PA – Partnership Agreement
The Partners – FDA (HAFW6, WEAC) and AK DEC POC – Point of Contact
SME – Subject Matter Experts
U.S.C. – United States Code
IV. GOALS, OBJECTIVES, AND INTENDED OUTCOMES
Currently the United States has limited radio-analytical capacity nationwide due to: resources required for establishing and sustaining laboratory infrastructure and expertise, and a global shortage of radio-analytical expertise. This project will develop radionuclide capability in the state of Alaska which will be beneficial for routine annual radionuclide monitoring but more importantly for capacity in emergency response if needed.
Additionally, the Food and Drug Administration and Alaska Department of Environmental Conservation have annually been monitoring coastal finfish samples in response to the Fukushima event at the request of the public and the Fukushima Interagency Workgroup.
Our objective is to provide training/expertise on use of the portable Gamma-ray analysis system and continued sampling and monitoring of coastal finfish in response to the Fukushima event.
This will ensure increased public health/safety in the event of a crisis, promote the interagency cooperation needed to successfully achieve common goals in public health, and avoid duplication of sampling efforts by the state and federal agencies thereby saving valuable resources.
- FDA will loan to ADEC existing equipment (Portable Gamma-Ray Analysis System) needed for sample analysis. The equipment is subject to the same accountability rules as if purchased for FDA use, but may be loaned under an agreement as provided in Staff Manual Guide 2620.4, Loan of Personal Property. See also statement in which “borrower” is responsible for damage and/or repairs of equipment.
- FDA will provide training as needed to AK DEC employees on use of the Portable Gamma-Ray Analysis System.
- FDA will provide assistance and technical support for the unit.
- FDA will process the data generated from sample analysis and provide a final report of analytical results to AK DEC.
- FDA will collaborate with AK DEC to develop a list of finfish species to be sampled and analyzed.
- FDA’s Winchester Engineering and Analytical Center (FDA WEAC) interprets the data, evaluates the quality control (QC), and if any QC anomalies are observed, investigates the outlier(s) and takes corrective action as necessary.
- FDA WEAC also monitors long term QC performance and performs periodic trend analysis. Control charts of the data are available to AK DEC upon request.
- FDA WEAC will notify the AK DEC Environmental Health Laboratory (AK DEC EHL) via email of the compliance status of QC analyses prior to the release of data.
- AK DEC will coordinate the collection and analyses of finfish species and/or food samples from designated areas as mutually agreed upon.
- AK DEC will ensure these samples are collected in a timely fashion or within agreed upon time frame.
- AK DEC will package and transport the samples as mutually agreed upon to the AK DEC Laboratory.
- AK DEC will provide two radionuclide standards needed for the portable Gamma-ray analysis system.
- AK DEC will electronically transfer analytical results to WEAC laboratory.
- AK DEC EHL receives samples, homogenizes the matrix, and places the homogenate in a container, which is placed in the gamma-ray analysis analyzer for data collection per the AK DEC EHL standard operating procedure (SOP) number SOP-Chemistry- 034.
- AK DEC EHL will also collect quality control data per its SOP-Chemistry-034.
- Once the data are collected, AK DEC EHL electronically transfers the files to FDA WEAC.
- AK DEC will share sample collection information in timely manner to FDA to incorporate into the FACTS system.
- Once FDA WEAC completes the data analysis and reports the data to HAF-W6 using the FDA designated data reporting system, FDA HAF-W6 reports the data to the Alaska Office of the State Veterinarian (OSV). The OSV notifies AK DEC EHL of receipt of the results, allowing AK DEC EHL to close out the pertinent work order.
- Partners will provide personnel needed for training session.
- Partners will individually fund any travel expenses associated with training.
- AK DEC will individually fund sample collections performed from their operating budget.
VII. LEGAL AUTHORITY
The purpose of this partnership agreement is to foster interaction, cooperation and coordination between the parties in the furtherance of the public health. No consideration has been given or received by either party to enter this agreement. It is not legally binding and does not constitute a promise on the part of either party for performance. It does not create a legally enforceable contract and the parties agree that no remedies at law or equity will be sought by either party for non-performance of this agreement. It does not impose additional legal duties, rights, benefits, or responsibilities, or remedies of either the parties or of third party. This partnership agreement imposes no duty on either party to act or to refrain from acting.
VIII. INFORMATION DISCLOSURE
Access to non-public information, where appropriate, shall be governed by separate Confidentiality Disclosure Agreements entered into under the authority of 21 C.F.R. §
20.88 and in which the Partners will agree and certify in writing that they shall not further release, publish or disclose such information and that they shall protect such information in accordance with the provisions of 21 U.S.C. 331(j), 21 U.S.C. 360j(c), 18 U.S.C. 1905, 5 U.S.C. § 552(a), 21 C.F.R. Part 20 and other applicable laws and regulations governing the confidentiality of such information. No proprietary data, trade secrets or personal privacy information shall be disclosed among the Partners unless permitted by applicable law. Parties seeking to enter into Confidentiality Disclosure Agreements should contact ORA’s Office of Strategic Policy and Operational Planning/ Division of Information Disclosure by sending a request via email to ORAInfoshare@fda.hhs.gov.
IX. ASSESSMENT AND EVALUATION
Partners to this PA will make all attempts, at a minimum annually, but may try to meet quarterly to discuss the outcome of current partnership, evaluate usefulness, and make modifications, as needed.
- Interim monitoring will occur monthly for each functional element.
- An annual review for each functional element of this PA will be completed by representatives from each partner. Review of the extent to which the PA enhances the sharing of resources to meet each partner’s mission.
- Review of the extent to which the PA achieves maximum consumer protection for public and health safety.
- Partners will identify new areas for developing partnership activities and agreements.
- As necessary and appropriate, evaluate and review materials provided and shared by each partner.
X. CONCLUSION AND RECOMMENDATION
Based on the annual evaluations performed, the evaluators will jointly prepare several options for follow-up partner actions, if and when appropriate, for approval by the signatories to this agreement.
PARTNERSHIP AGREEMENT BETWEEN U.S. FOOD AND DRUG ADMINISTRATION AND THE ALASKA DEPARTMENT OF ENVIRONMENTAL CONSERVATION
Accepted for the Food and Drug Administration:
Erik P. Mettler
FDA Office of Regulatory Affairs
Office of Partnerships and Operational Policy
Program Division Director
FDA Office of Regulatory Affairs
Office of Human and Animal Food Operations West, Division 6
FDA Office of Regulatory Affairs
Office of Regulatory Science, Winchester Engineering & Analytical Center
Accepted for (Partnering agency(s)):
Christina Carpenter Date Signed
Division of Environmental Conservation
Alaska Department of Environmental Conservation