USDA United States Department of Agriculture

Food Safety and Inspection Service (FSIS) Equivalence FinaalnRdule “Mandatory IFnisnpaecltRiounloef Fish of the order Siluriformes and Products Derived Derived from Such Fish” from Such Fish” 2

Food Safety and Inspection Service Mission in Action We are the public health agency in the USDA responsible for ensuring that meat, poultry, and processed egg products are safe, wholesome, and accurately labeled. Our Authority Federal Meat Inspection Act (FMIA), 1906 Agricultural Marketing Act (AMA), 1946 (select sections) Poultry Products Inspection Act (PPIA), 1957 Egg Products Inspection Act (EPIA), 1970 Humane Methods of Slaughter Act (HMSA), 1958 3

Food Safety and Inspection Service Foodborne Illness How FSIS prevents foodborne illness 4

Where We Work North MarianaIslands Hawaii _ _ . ,. Puerto Rico Alaska US Vwgin Islands http://www.fsis. usda.gov/wps/porta 1/information al/districtoffices 5

the Department of Agriculture Food Safety and Inspection Service: Mandatory Inspection of Siluriformes Fish – Farm Bill Approximately every five years, Farm Bills are developed and proposed by the U.S. Congress Signed into law by the President Sets forth guidance and policy for the Department of Agriculture

Food Safety and Inspection Service: Mandatory Inspection of Siluriformes Fish – 2008 Farm Bill The 2008 Farm Bill Amended the Federal Meat Inspection Act to put “Catfish” under FSIS’s jurisdiction

Food Safety and Inspection Service: Mandatory Inspection of Siluriformes Fish – Proposed Rule On February 24, 2011, FSIS published the proposed rule, “Mandatory Inspection of Catfish and Catfish Products” It proposed a new Subchapter of FSIS regulations FSIS asked for comment on the definition of “Catfish” and other issues

Food Safety and Inspection Service: Mandatory Inspection of Fish – 2014 Farm Bill The 2014 Farm Bill Amended the Federal Meat Inspection Act to provide that: The term “amenable species” now includes fish of the order Siluriformes

Food Safety and Inspection Service: Mandatory Inspection of Fish – Final Rule On December 2, 2015, FSIS published the final rule, “Mandatory Inspection of Fish of the Order Siluriformes and Products Derived From Such Fish” The final rule establishes an inspection program for Siluriformes fish and fish products Domestic and imported Siluriformes fish and fish products will now be inspected by FSIS 10

Siluriformes Fish and Fish Products: Species now under FSIS’s jurisdiction ORDER FAMILY ACCEPTABLE COMMON OR USUAL NAME IN THE U.S. Blue Catfish or Catfish Channel Catfish or Catfish White Catfish or Catfish Black Bullhead or Bullhead or Catfish Yellow Bullhead or Bullhead or Catfish Brown Bullhead or Bullhead or Catfish Flat Bullhead or Bullhead or Catfish Whitespotted fish or Chinese fish Broadhead Clarias Fish Walking Clarias Fish Swai or Sutchi or Striped Pangasius or Tra Basa Mekong Giant Pangasius Giant Pangasius GENUS AND SPECIES Ictalurus furcatus Ictalurus punctatus Ameiurus catus Ameiurus melas Ameiurus natalis Ameiurus nebulosus Ameiurus platycephalus Clarias macrocephalus Clarias batrachus Pangasianodon (or Pangasius) hypophthalmus Pangasius bocourti Pangasius gigas Pangasius sanitwongsei Ictaluridae SILURIFORMES* Clariidae Clarias fuscus Pangasiidae 11

Food Safety and Inspection Service: Code of Federal Regulations Where are FSIS Regulations Found? CODE OF FEDERAL REGULATIONS (CFR) at www.ecfr.gov Title 9 Chapter III – Food Safety and Inspection Service, Department of Agriculture Subchapter A – Agency Organization and Terminology; Mandatory Meat and Poultry Products Inspection and Voluntary Inspection and Certification Subchapters B and C (reserved) Subchapter D – Food Safety and Inspection Service Administrative Provisions Subchapter E – Regulatory Requirement Under the Federal Meat Inspection Act and the Poultry Products Inspection Act Subchapter F – Mandatory Inspection of Fish of the Order Siluriformes and Products of Such Fish (Parts 530-561.2)

Food Safety and Inspection Service: Regulatory Timeline September 1, 2017 December 2, 2015 Final Rule published March 1, 2016 Effective Date 18-month Full 90 days Transitional enforcement Period

Food Safety and Inspection Service: Enforcement during 18-Month Transitional Period Adulterated product: Produced without the benefit of inspection Fails to present for re-inspection (imports) Prohibited residue Undeclared allergen Prepared, packed, or held under conditions that contaminate it Misbranded product: Product offered for sale as “Catfish,” but does not contain fish of the family Ictaluridae Net weight over-declared Missing label

Implementation Strategy Provide outreach to affected establishments producing Siluriformes fish and fish products, to ensure that they understand the new requirements. Conduct sampling and testing of Siluriformes fish and fish products for species and residues to ensure that product is not adulterated or misbranded.

Implementation Strategy Starting March 1, 2016, FSIS began: Assigning inspection program personnel to domestic establishments that slaughter and slaughter and process Siluriformes. Visiting domestic Siluriformes fish processing-only establishments (includes establishments that process more than Siluriformes), at least once per quarter. . 16

Initial Documentation Requirements for Foreign Countries Siluriformes Fish: Initial Documentation Requirements for Foreign Countries By the effective date, March 1, 2016, foreign countries that currently export Siluriformes fish and fish products to the U.S., and intend to continue during the 18- month Transitional Period, had to submit: A list of establishments with establishment name and number Documentation to demonstrate their authority to regulate the growing and processing of Siluriformes fish for human food and assure compliance with the Food and Drug Administration’s (FDA) good manufacturing practices, HACCP plans, Sanitation Control Procedures, and other regulatory requirements www.fsis.usda.gov/siluriformes 17

18-Month Transitional Period Siluriformes Fish: 18-Month Transitional Period During the 18-month Transitional Period: FSIS will recognize the initial documentation foreign countries submit Foreign countries seeking to continue exporting Siluriformes fish and fish products to the United States after full enforcement must initiate a request for equivalence and provide documentation showing its system is equivalent by September 1, 2017 FSIS has encouraged foreign countries to initiate this process as soon as possible 18

Food Safety and Inspection Service: Implementation – Imported Product Starting April 15, 2016, FSIS began: Reinspecting imported product on an at least quarterly basis Informing importers/brokers which shipments are selected for reinspection Selected import shipments must be presented at an Official Import Inspection Establishment for reinspection by FSIS. Reinspection will include testing for residues and speciation 19

18-Month Transitional Period Siluriformes Fish: 18-Month Transitional Period During the 18-month Transitional Period: If FSIS finds imported Siluriformes fish and fish products that are adulterated (i.e., contain a prohibited residue or have been held under insanitary conditions that result in direct product contamination) or misbranded (i.e., labeled “Catfish” when the product does not contain fish of the family Ictaluridae or the net weight is over- declared), the products will be refused entry. 20

FSIS has set up an email box where questions Food Safety and Inspection Service: Contacting FSIS FSIS has set up an email box where questions can be submitted: AskFish@fsis.usda.gov. FSIS’s Siluriformes web page has extensive information, including News and Information, Statutes and Regulations, Reports and MOU’s, and Resources: http://www.fsis.usda.gov/siluriformes.

Food Safety and Inspection Service: Questions?