This Memorandum of Understanding (MOU)number 225-14-0009 between the Food Safety and Inspection Service (FSIS), United States Department of Agriculture (USDA), and the Food and Drug Administration (FDA), United States Department of Health and Human Services, is intended to improve interagency cooperation on food safety and fraud prevention and to maximize the effectiveness of personnel and resources related to examination and inspection of Siluriformes fish and fish products.
MEMORANDUM OF UNDERSTANDING
Between
The Food Safety and Inspection Service
United States Department of Agriculture
And
The Food and Drug Administration
United States Department of Health and Human Services
I. Purpose
This Memorandum of Understanding (MOU) between the Food Safety and Inspection Service (FSIS), United States Department of Agriculture (USDA), and the Food and Drug Administration (FDA), United States Department of Health and Human Services, is intended to improve interagency cooperation on food safety and fraud prevention and to maximize the effectiveness of personnel and resources related to examination and inspection of Siluriformes fish and fish products.
II. Background
The Agricultural Act of 2014 (2014 Farm Bill), enacted February 7, 2014, directs USDA to execute an MOU with FDA for the following purposes:
1. To improve interagency cooperation on food safety and fraud prevention, building upon any other prior agreements.
2. To maximize the effectiveness of limited personnel and resources by ensuring that –
a. inspections conducted by FSIS satisfy requirements under the Federal Food, Drug, and Cosmetic Act
b. inspections of shipments and processing facilities for fish of the order Siluriformes by the agencies are not duplicative; and
c. any information resulting from examination, testing, and inspections conducted is considered in making risk-based determinations, including the establishment of inspection priorities.
This MOU sets forth the working arrangements between the agencies to facilitate each agency’s efforts to discharge its responsibilities related to the regulatory oversight of fish and fish products and to achieve the purposes identified in the 2014 Farm Bill. It builds upon other prior agreements between the agencies.
II. Statutory Authorities
FSIS administers the Federal Meat Inspection Act (21 U.S.C. 601-695), as amended, notably, by the 2008 Farm Bill (Pub.L. 110-246, §4(a), title XI, §11016(b)(1)(A), June 18, 2008; 122 Stat. 1664, 2130), and further amended by the 2014 Farm Bill (Pub.L. 113-79, title XII, §12106(a)-(c), February 7, 2014; 128 Stat. 980-982).
FDA operates under authorities including the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301, et seq.), the Public Health Service Act (42 U.S.C. 201, et seq.), and the Fair Packaging and Labeling Act (15 U.S.C. 1451, et seq.).
III. Substance of Agreement
A. It is mutually agreed that:
1. The agencies will plan for the orderly transition, in phases, from FDA to FSIS of primary regulatory oversight of domestically produced and imported Siluriformes fish and fish products, as provided in the final rule.
2. The agencies will follow the provisions of this MOU as appropriate during the transition period and fully thereafter.
3. In dual jurisdiction establishments that prepare, pack, hold, or otherwise handle both Siluriformes fish and fish products and other fish and fish products, the agencies will follow the procedures for dual jurisdiction establishments set out in MOU number 225-99-2001, except as superseded for certain information sharing by MOU 225-12-0007 (section IV, paragraph 9 and Appendix B).
4. The agencies will coordinate in issuing regulations and guidance and in conducting outreach specific to Siluriformes fish and fish products.
5. The agencies will exchange information relevant to the regulatory oversight of Siluriformes fish and fish products as set out in MOU number 225-12-0007.
6. Each agency will take advantage of the inspectional capabilities of the other agency to achieve the maximum utilization of resources with regard to Siluriformes fish and fish products, when appropriate and as resources permit.
B. FSIS will:
1. Exercise primary regulatory oversight over Siluriformes fish and fish products.
2. Inform FDA if an apparent violation is encountered involving fish and fish products other than Siluriformes.
C. FDA will:
1. Not inspect Siluriformes fish and fish products at domestic and foreign establishments that grow, slaughter, or process such fish and fish products unless requested by FSIS.
2. Not sample or analyze Siluriformes fish and fish products bearing an official USDA inspection legend or an official USDA import mark, unless requested by FSIS.
3. Continue to exercise regulatory oversight over all other fish and fish products.
4. Inform FSIS when an apparent violation is encountered involving Siluriformes fish and fish products.
IV. Liaison Officers
To facilitate the activities described in this MOU, each agency will establish liaisons specified in Appendix A to this MOU.
V. Effective Date, Termination, and Modification
This MOU will become effective when signed by the designated representatives of both agencies and shall continue in effect unless modified or terminated by mutual written consent of the agencies.
Signed on this 30th day of April, 2014.
ACCEPTED AND APPROVED: ACCEPTED AND APPROVED:
Food Safety and Inspection Service U.S. Food and Drug Administration
See the detailed momerandum at www.fda.gov