PARTNERSHIP AGREEMENT BETWEEN U.S. FOOD AND DRUG ADMINISTRATION AND SAN JUAN DISTRICT (HAF-E4)
THE COMMONWEALTH of PUERTO RICO
DEPARTMENT OF CONSUMER AFFAIRS (DACO)
The purpose of this developmental Partnership Agreement (PA) is to document and formalize a commitment to advance the initial expansion of domestic mutual reliance utilizing ongoing coordination of public health and consumer protection through collaboration between the United States Department of Health and Human Services (HHS), Food and Drug Administration (FDA) Office of Regulatory Affairs (ORA), Division of Human and Animal Foods - San Juan District East-4 (HAF-E4) and the Puerto Rico Department of Consumer Affairs (DACO), together referred to as “the Partners.”
Partner activities will support FDA in the implementation and enforcement of the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.S.C. § 301 et seq.). FDA’s responsibilities under the Act include the regulation of consumer products, including foods, drugs, and cosmetics, located in the Commonwealth of Puerto Rico.
Similarly, this PA will support Puerto Rico’s adoption of FDA regulation in the implementation and enforcement of consumer products requirements under Law number 5 of April 23, 1973 “Organic Law of the Department of Consumer Affairs” to be affected under special emergency situations that may impact the safety or effectiveness of mutually regulated consumer products offered or held for sale and distribution within the Commonwealth of Puerto Rico.
This PA does not affect or supersede any existing or future agreements, arrangements, contracts, or cooperative agreements between the Partners and does not affect the ability of the Partners to enter into other agreements or arrangements related to this PA.
This Partnership Agreement covers a period of three (3) years from the date of signature. This time frame will give the Partners sufficient time to measure the PA outcomes, modify the PA if warranted, and renew the PA with consent of both Partners.
This PA is effective upon signing and shall remain in effect for three years unless terminated by either Partner upon thirty (30) business days advance written notice to the other Partner.
III. DEFINITIONS AND ACRONYMS
DACO: The Commonwealth of Puerto Rico Department of Consumer Affairs
FDA: Food and Drug Administration
HAF-E4: Human and Animal Food Operations (FL, SJN Division-4)
HHS: U.S. Department of Health and Human Services
ORA: FDA Office of Regulatory Affairs
Partnership: Collaboration, cooperation
PA: Partnership Agreement
PR: Commonwealth of Puerto Rico
IV. GOALS, OBJECTIVES, AND INTENDED OUTCOMES
Both agencies have similar responsibilities in consumer protection related to food, drug, and cosmetic products. The intent of this PA is to expediently address emergency consumer protection efforts, minimize duplicative efforts, and further domestic mutual reliance.
Collaborative work and resource optimization may include:
A. Manage emergency response activities
B. Enhance and coordinate investigatory communication and activities for consumer products
C. Partner training
D. PA monitoring, assessment, and evaluation
The Partners will identify and define objectives, audiences, requirements, coordination, oversight, and execution for these activities.
All Partners agree that nothing in this PA relieves any party from its responsibilities to protect public health and safety nor any regulatory responsibilities granted to their respective agencies.
A. Manage Emergency Response Activities:
Emergency situations, such as efforts to remove from the market certain unapproved products that purport to prevent, treat, mitigate, or cure disease, serve as a trigger for increased communication between both agencies.
Partners will engage in training and exercises to further support prompt, coordinated, and effective investigatory operations, and analyses of samples during commodity investigations and foodborne illness outbreaks or to detect/identify un-approved ingredients. The Partners will provide support for (joint) emergency response with multidisciplinary expertise in epidemiology, microbiology, chemistry, radiological, sanitation, and environmental science. Training may address, but is not limited to:
1. Responding to large-scale outbreak of contaminated commodities or other emergencies to protect public health
2. Responding to intentional adulteration or contamination of jointly regulated commodities
B. Investigatory Coordination/Communication for Consumer Products: Partners seek to collaborate on mutually agreed upon activities in regulatory areas as they pertain to products falling within the statutory authorities of both Partners.
C. Partner Training: FDA will provide DACO employees with guidance and training covering FDA laws, regulations, and procedures (documentation, recalls, press releases, etc.) as they pertain to products falling within its statutory authority. Training DACO personnel on FDA regulations and procedures may serve to enhance DACO’s effectiveness in identifying possibly violative products found at the retail level.
D. PA Monitoring, Assessment, and Evaluation:
1. The Partners will meet, at least annually, to evaluate the progress of the PA during the completed period(s).
2. The Partners will evaluate whether the PA enhances sharing of resources to meet each Partner’s goals, objectives, and intended outcomes
3. As necessary and appropriate, the Partners will evaluate, and review materials provided by each Partner.
4. The Partners will identify, establish, and monitor key mutual reliance metrics for performing an annual evaluation of this PA.
5. The Partners will collectively provide an “Annual Evaluation fillable .pdf” which includes ongoing outputs and outcomes.
A. Will serve as an educational resource for DACO to help support accountability, commitment to public health, communication, integrity, respect, and quality within their commodity programs. These core values will strengthen consumer protection and public health.
B. Will identify collaborative opportunities, such as participating in training and education, conducting outreach, assisting in regulatory investigations, and collaborating in emergency response activities.
C. Will assume full responsibility for performing all label and labeling review, and laboratory testing that may be needed to determine product conformance or nonconformance with FDA regulations.
D. Will complete analytical work and report the results to DACO within thirty (30) business days following receipt of the sample by the proper laboratory facility, whenever feasible.
A. In any situation or emergency that could compromise the health of the consumer, DACO will request FDA expertise to jointly inspect or investigate commodities which are deemed not suitable for human consumption.
B. DACO will request FDA support or action according to its established procedures for retail case development and requesting FDA action, as appropriate.
C. DACO will share information with FDA and maintain proper information sharing agreements.
A. The Partners can participate in joint retail inspections or investigations.
B. Signatories for each Partner will assign points of contact (POCs), as needed, for each goal of this agreement.
C. POCs will ensure progress, clear lines of communication, and appropriate dissemination of information to managers.
D. FDA will complete documenting any pending case within thirty (30) business days of obtaining the relevant information via a joint inspection or investigation, when feasible. All legally releasable non-public information pertinent to the event will be referred to DACO for appropriate follow-up.
E. In the case of any violative products encountered at a retail location during an investigation, FDA will contact DACO for consultation and any final decisions and actions regarding the products involved at retail will be made by DACO. DACO may assume the case and continue with administrative actions, as appropriate.
F. The Partners will identify, establish, and monitor key mutual reliance metrics with assistance from the ORA Office of Partnerships.
G. The Partners will complete a joint annual evaluation report, with support from the ORA Office of Partnerships, which includes ongoing PA outputs and outcomes to document program accomplishments and areas for enhancement.
The Partners agree to demonstrate mutual commitment to shared goals and objectives within their operational and fiscal resource constraints.
Resources will be identified to accomplish objectives and may include as needed, but are not limited to:
E. Databases and technological transfer
F. Guidance and technical support
This PA describes in general terms the basis upon which the Partners intend to cooperate in these activities. It does not create binding, enforceable obligations against any Partner.
All activities undertaken pursuant to this PA are subject to availability of personnel, resources, and appropriated funds, including funding for purchasing surveillance samples to be collected by DACO and analyzed by FDA in the case of targeted goods suspected of being in violation of statutory requirements to ensure safety and efficacy.
VII. LEGAL STATUS
No consideration has been given or received by either Partner to this PA. This PA is not legally binding and does not constitute a promise on the part of either Partner for performance. It does not create a legally enforceable contract and the Partners agree that no remedies at law or equity will be sought by either Partner for non-performance of this PA. It does not impose additional legal duties, rights, benefits, or responsibilities, or remedies of either the Partners or of a third party. This PA imposes no duty on either Partner to act or to refrain from acting.
VIII. INFORMATION DISCLOSURE
DACO will maintain both a Long-Term Food, Feed, and Cosmetic 20.88 Information Sharing Agreement and a Long-Term Drug 20.88 Information Sharing Agreement to facilitate the exchange of information. These efforts are intended to support further cooperation among our agencies including official information sharing between both agencies.
Access to non-public information, where appropriate, shall be governed by separate Information Sharing Agreements in accordance with 21 C.F.R. Part 20. Under 21 C.F.R. § 20.88 (20.88 Information Sharing Agreement, state agencies must agree and certify in writing that they shall not further release, publish, or disclose FDA non-public information, and that they shall protect such information from public disclosure. No proprietary data, trade secrets, or personal privacy information shall be disclosed among the Partners unless permitted by applicable law.
To confirm the applicability of an existing 20.88 Information Sharing Agreement, to enter into a 20.88 Information Sharing Agreement, and prior to sharing any FDA-provided information Partners shall contact ORA’s Office of Strategic Planning and Operational Policy, Division of Information Disclosure Policy (DIDP) by sending a request via email to: ORAInfoshare@fda.hhs.gov.
IX. ASSESSMENT AND EVALUATION
This PA may be amended or modified by mutual consent of the Partners. The Partners will review the PA and goals annually. The Partners will make all reasonable attempts to discuss the current PA, capture key mutual reliance metrics and activities, evaluate its usefulness, and make modifications, as needed. During the annual review and evaluation meeting, the Partners will jointly prepare options for follow-up. If new areas for developing PA activities are identified and agreed upon, this PA may be revised to reflect them.
Any Partner on its initiative may submit a proposed amendment or modification in writing for review. Modifications and amendments will be tracked and documented throughout the duration of the PA and will be reviewed at least annually during the annual review and maintained for historical purposes.
X. STATEMENT OF NO FINANCIAL OBLIGATIONS
Signature of this PA does not constitute a financial obligation on the part of either Partner. Each Partner will use and manage its own funds in carrying out the purpose of this PA. Permanent transfers of funds or items of value is not authorized under this PA.
XI. ACTIVITY LIAISON OFFICIALS:
Execution of this Partnership Agreement will be confirmed by direct communication between the liaison officers listed below for the two agencies or between the top officials for each agency (FDA San Juan District Director and Secretary of the PR Department of Consumer Affairs) or their designees. Such communication can be in person, by phone, or by any other electronic means.
FDA San Juan District Office POCs:
- State Liaison
- Emergency Response Coordinator
- Public Affair Specialist
- Interim Secretary
XII. CONCLUSIONS AND RECOMMENDATIONS:
The Partners agree to the provisions written in this PA, subject to availability of resources.
[Signatories of Responsible Parties Must Include Printed Name, Signed Name, and Date of Signature]
Accepted for the Food and Drug Administration:
Erik P. Mettler
Office of Partnerships and Policy
FDA Office of Regulatory Affairs
FDA Office of Regulatory Affairs
Office of Human and Animal Food Operations
Accepted for the Food and Drug Administration:
San Juan District Director
FDA Office of Regulatory Affairs
Division of Human and Animal Food East-4
Accepted for DACO:
Puerto Rico Department of Consumer Affairs (DACO)