# Mandatory Inspection of Fish of the Order Siluriformes and Products Derived From Such Fish > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2015-29793 ## Record - **Collection:** Federal Register - **Document type:** Rule - **Published:** December 2, 2015 - **Citation:** 80 FR 75590 ## Text DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service 9 CFR Parts 300, 441, 530, 531, 532, 533, 534, 537, 539, 540, 541, 544, 548, 550, 552, 555, 557, 559, 560, and 561 [Docket No. FSIS-2008-0031] RIN 0583-AD36 Mandatory Inspection of Fish of the Order Siluriformes and Products Derived From Such Fish AGENCY: Food Safety and Inspection Service. ACTION: Final rule. SUMMARY: The Food Safety and Inspection Service (FSIS) is amending its regulations to establish a mandatory inspection program for fish of the order Siluriformes and products derived from these fish. These final regulations implement the provisions of the 2008 and 2014 Farm Bills, which amended the Federal Meat Inspection Act, mandating FSIS inspection of Siluriformes. DATES: Effective Date: March 1, 2016. On the effective date (March 1, 2016), Siluriformes fish and fish products are under FSIS jurisdiction. By March 1, 2016, foreign countries seeking to continue exporting Siluriformes fish and fish products to the United States during the transitional period are required to submit lists of establishments (with the establishment name and number) that currently export and will continue to export Siluriformes fish and fish products to the United States. Foreign countries are also required to submit documentation showing that they currently have laws or other legal measures in place that provide authority to regulate the growing and processing of fish for human food and to assure compliance with the Food and Drug Administration's (FDA) regulatory requirements in 21 CFR part 123, Fish and Fishery Products. Transitional Period (transition to complete implementation): Beginning on March 1, 2016 and continuing until September 1, 2017, FSIS will conduct inspection and exercise broad enforcement discretion in domestic establishments that slaughter or slaughter and process and distribute Siluriformes fish and fish products. Foreign countries seeking to continue to export Siluriformes fish and fish products to the United States after the transitional period has expired are required to submit to FSIS by September 1, 2017 adequate documentation showing the equivalence of their Siluriformes inspection systems with that of the United States. Foreign countries submitting such documentation by the deadline are permitted to continue exporting Siluriformes fish and fish products to the United States while FSIS undertakes an evaluation as to equivalency. Date of Full Enforcement (September 1, 2017): FSIS will fully enforce these regulations in domestic Siluriformes fish products and fish processing establishments. Foreign countries seeking to continue exporting Siluriformes fish and fish products to the United States upon full enforcement are required to submit their documentation showing equivalence by this date. FOR FURTHER INFORMATION CONTACT: Daniel Engeljohn, Assistant Administrator, Office of Policy and Program Development, FSIS, U.S. Department of Agriculture, 1400 Independence Avenue SW., Washington, DC 20250-3700, (202) 205-0495. SUPPLEMENTARY INFORMATION: Executive Summary The 2008 Farm Bill amended the Federal Meat Inspection Act (FMIA), to make “catfish” a species amenable to the FMIA and, therefore, subject to FSIS inspection. In addition, the 2008 Farm Bill gave FSIS the authority to define the term “catfish.” On February 24, 2011, FSIS published a proposed rule that outlined a mandatory catfish inspection program and presented two options for defining “catfish”: One option was to define catfish narrowly as those fish belonging to the family Ictaluridae. The other option was a broader definition, all fish of the order Siluriformes (76 FR 10434). FSIS sought public comments on the scope of the definition in the proposed rule. The Agency proposed regulatory requirements for mandatory catfish inspection that were adapted from the meat inspection regulations. The 2014 Farm Bill, enacted on February 7, 2014, amended the FMIA to remove the term “catfish” and to make “all fish of the order Siluriformes” subject to FSIS jurisdiction and inspection. As a result, FSIS inspection of Siluriformes is mandated by law. This final rule adopts all the regulatory requirements outlined in the February 2011 proposal, with the following changes: • The term “catfish” defined in proposed 9 CFR part 531 and used throughout the proposed regulatory text, is replaced in this final rule by the term “fish of the order Siluriformes,” “Siluriformes fish,” or simply “fish,” understood to mean, for purposes of the final regulations, any fish of the order Siluriformes. • The retail store exemption includes, as an exempt retail operation, the slaughter of fish at retail stores or restaurants for consumers who purchase the fish at those facilities, and in accordance with the consumers' request. • Fish with unusual gross deformities caused by disease or chemical contamination (rather than merely with gross deformities) are not to be used for human food (9 CFR 539.1(d)). • The labeling regulations (9 CFR 541.7) permit the use of the term “catfish” only on labels of fish classified within the family Ictaluridae, consistent with provisions of the Federal Food, Drug, and Cosmetic (FD&C) Act (21 U.S.C. 321d (a) and 343(t)). Fish of the order Siluriformes, from families other than Ictaluridae, must be labeled with an appropriate common or usual name. • The labeling regulations (9 CFR 541.7) require packages of Siluriformes fish and fish products that are not ready-to-eat to bear safe-handling instructions to include “fish” in the rationale statement, i.e., “This product was prepared from inspected and passed fish, ”and in the labeling statements, i.e., “Keep raw fish from other foods. Wash working surfaces (including cutting boards), utensils, and hands after touching raw fish.” • The labeling regulations (9 CFR 541.7) to clarify that the labeling of fish covered commodities sold by a retailer bear country of origin and method of production information, in compliance with the requirements in 7 CFR part 60, subpart A, Country of Origin Labeling for Fish and Shellfish. • The import inspection regulations for Siluriformes fish and fish products (9 CFR part 557) to make them consistent with the September 19, 2014, rule amending the FSIS regulations for imported meat, poultry, and egg products (79 FR 56220). • The regulations include provisions for State-Federal, Federal-State Cooperate Agreements; State Designations (9 CFR part 560) and authorize coordination with States that have fish inspection programs to select certain establishments to participate in an interstate shipment program. These changes reference regulations that took effect after the proposed rule on catfish inspection was published. The regulations incorporate requirements for establishments to maintain written recall plans (9 CFR 532.2) and to notify the FSIS District Office of any adulterated or misbranded product that the establishment has received or shipped in commerce (9 CFR 537.3). These changes reference regulations that took effect after the proposed rule on catfish inspection was published. • The regulations on official marks and devices for identifying inspected-and-passed fish and fish products (9 CFR 541.2(d)) require whole, gutted fish carcasses to bear the official inspection legend or to be properly packaged in an immediate container marked with the official inspection legend, as well as all other required labeling features. • The preamble discussion explains that the net weight for ice-glazed fish is determined on a rigid-state basis, as provided in the National Institute of Standards and Technology (NIST) Handbook 133, “Checking the Net Contents of Packaged Goods.” • The regulatory requirements in this final rule will be effective 90 days after its publication. FSIS will implement the regulatory requirements during an 18-month timeframe. • In addition, during the 18-month transitional period, foreign countries are to begin submitting to FSIS documentation demonstrating the equivalency of their inspection systems for Siluriformes fish and fish products. The annualized cost to the Siluriformes fish domestic industry is $326.55 thousand. 1 This would be an additional annualized average net direct cost to this domestic fish industry of about $0.0008 per pound of processed Siluriformes fish and Siluriformes products. For comparison, the average price received by domestic processors for domestic catfish (of the order Siluriformes) products was considerably greater at $3.04 per pound, in 2013. Furthermore, the additional annualized average direct cost to FSIS is $2,604.4 thousand. On the other hand, the decreased annualized average direct cost to FDA and to the U.S. Department of Commerce's (USDC) National Oceanic and Atmospheric Administration (NOAA)/National Marine Fisheries Service (NMFS) is $1,490 thousand because of this final rule. The net difference of these annualized average direct costs to these three Federal government agencies is $1,114.40 thousand. Therefore, the annualized (at 7 percent) average net direct cost to the Siluriformes fish domestic industry and to the three affected Federal government agencies is $1,440.95 thousand. 1 Annualized present value of average costs is at a 7 percent discount rate over 10 years. Table 1—Projected Summary Additional Annualized Average Net Direct Costs (Domestic) of the Final Rule Affected sectors of the domestic economy Additional annualized cost, over 10 years, discounted $thousands 7 percent 3 percent Siluriformes Fish Industry $326.55 $317.78 Federal Government Agencies 1,114.40 1,097.22 Total 1,440.95 1,414.99 Table of Contents Background I. 2008 Farm Bill II. 2011 Proposed Rule III. 2014 Farm Bill IV. Use of the Terms “Catfish” and “Fish” in Preamble Discussion V. Scientific Classification (Taxonomy) of the Catfishes VI. Current Inspection of Domestic and Imported Catfish VII. Public Health Considerations: Potential Chemical and Microbiological Contaminants VIII. Summary of Proposed and Final Regulatory Requirements A. Organization of Inspection Operations B. Definitions C. Establishments Requiring Inspection; Grant and Approval of Inspection D. Facility Requirements for Inspection E. Pre-harvest and Transfer to Processing Establishment F. Sanitation and Hazard Analysis Critical Control Point (HACCP) System Requirements for Processing Facilities G. Mandatory Dispositions; Performance Standards Respecting Physical, Chemical, or Biological Contaminants H. Handling and Disposal of Condemned and Inedible Materials I. Marks, Marking, and Labeling of Products and Containers 1. Official Marks and Devices 2. Labeling Requirements; Prior Approval of Labeling 3. Prevention of False or Misleading Labeling Practices 4. Net Weight and Retained Water 5. Nutrition Labeling Regulations J. Food Ingredients Permitted K. Ready-to-eat and Canned Fish Products: Control of Listeria monocytogenes L. Canned Products M. Accredited Laboratories N. Standards of Identity and Composition O. Exports P. Transportation in Commerce Q. Imported Products R. Demonstrating Equivalence of Foreign Systems 1. Program Administration 2. Legal Authority and Requirements Governing Catfish and Catfish Products Inspection 3. Document Evaluation and System Review 4. Maintenance of Standards S. Marking and Labeling of Imported Products IX. Proposed Regulations Under Other FMIA Subchapters A. Rules of Practice; Reference to Rules of Practice B. Detention, and Seizure and Condemnation 1. Detention 2. Seizure and Condemnation X. Records Required To Be Kept XI. Comments and Responses A. General Opposition B. The Definition of Catfish C. Risk Assessment D. Cost and Benefits Analysis E. Trade Barriers and Agreements F. Equivalency and Implementation G. Facilities Requirements and Schedule of Operations H. Definitions 1. “Adulterated” 2. “Slaughter” and “Slaughterhouse” 3. “Farm-raised” and “Wild-Caught” I. Labeling 1. Mark of Inspection 2. Species Identification and Prevention of False or Misleading Labeling Practices 3. Standards of Identity 4. Percent Approved Substances 5. Net Weight and Retained Water 6. Safe Handling Instructions 7. Country of Origin Labeling J. Pre-harvest and Transport Conditions K. Pathogen Reduction and Tolerances for Animal Drugs L. Limits for Retail Quantities M. Hard Copy Information N. Other Comments 1. Exemptions and Periodic Auditing 2. Use of Program Seals O. Cooperation With States P. Outreach and Training XII. FSIS Implementation XIII. Executive Orders 12866 and 13563 and Regulatory Flexibility Act A. Need for the Rule B. Baseline C. Catfish Consumption and Prices D. Alternative Regulatory Approaches Considered E. Expected Costs of the Final Rule F. Costs to Foreign Entities 1. Foreign Governments 2. Foreign Establishments G. Associated Costs to U.S. Consumers H. Expected Budgetary Impacts on FSIS and Other Government Agencies I. Break-Even Analysis 1. Possible Health Benefits Assessment Break-Even Analysis 2. Health Benefits—Removing Adulterated Products From the Market J. Regulatory Flexibility Act Assessment XIV. Paperwork Reduction Act XV. E-Government Act XVI. Executive Order 12988, Civil Justice Reform XVII. Expected Environmental Impact XVIII. Executive Order 13175, Indian Tribal Government XIX. USDA Non-Discrimination Statement XX. Additional Public Notification Background I. 2008 Farm Bill The Food, Conservation, and Energy Act of 2008 (Pub. L. 110-246, Section 10016(b)), known as the 2008 Farm Bill, amended the Federal Meat Inspection Act (FMIA) to provide that “catfish, as defined by the Secretary,” is an amenable species (21 U.S.C. 601 (w)(2)). Therefore, the 2008 Farm Bill placed catfish and catfish products under FSIS jurisdiction and inspection. The 2008 Farm Bill also added 21 U.S.C. 625, which provides that the sections of the FMIA dealing with ante-mortem and post-mortem inspection and humane slaughter (21 U.S.C. 603 and 604), inspection of carcasses and parts before their entry into establishments or further-processing departments (21 U.S.C. 605), and exemptions from inspection for custom and farm slaughter and processing and other exemptions (21 U.S.C. 623) do not apply to catfish. In addition, the 2008 Farm Bill revised 21 U.S.C. 606, which requires the appointment of inspectors to examine and inspect all meat food products prepared for commerce and provided that the examination and inspection of meat food products derived from catfish are to take into account the conditions under which catfish are raised and transported to processing establishments (21 U.S.C. 606(a) and (b)). II. 2011 Proposed Rule On February 24, 2011, FSIS published the proposed rule, “ Mandatory Inspection of Catfish and Catfish Products,” (76 FR 10434). The regulations proposed to implement the provisions of the 2008 Farm Bill. The proposed rule's comment period closed on June 24, 2011, 90 days after its publication. In May 2011, FSIS held two public meetings, in Washington, DC, and Stoneville, MS, to discuss the proposed rule. At those meetings, FSIS provided an overview of the proposed rule and provided the public with an opportunity to comment on the proposed regulation. Transcripts of the public meeting are available on the FSIS Web site at http://www.fsis.usda.gov/wps/wcm/connect/eefd3e0d-ea69-4c75-b1ac-ea4df9d133e4/Transcripts_05242011_Catfish_meeting.pdf?MOD=AJPERES and http://www.fsis.usda.gov/wps/wcm/connect/ddb209ab-6aa3-4953-9514-70a8532d3348/Transcripts_05262011_Catfish_meeting.pdf?MOD=AJPERES . III. 2014 Farm Bill On February 7, 2014, the Agricultural Act of 2014 (Pub. L. 113-79, Sec. 12106), known as the 2014 Farm Bill, amended Section 1(w) of the FMIA to remove the phrase “catfish, as defined by the Secretary,” and replace it with “all fish of the order Siluriformes,” thus including these fish among the amenable species under FSIS jurisdiction and inspection (21 U.S.C. 601(w)(2)). The 2014 Farm Bill also amended the 2008 Farm Bill instructing FSIS, in consultation with the Food and Drug Administration (FDA), to issue final regulations to carry out the amendments in a manner that ensures no duplication in inspection activities. In addition, the 2014 Farm Bill instructed FSIS to execute a Memorandum of Understanding (MOU) with FDA to improve interagency cooperation and to maximize the effectiveness of personnel and resources by ensuring that inspections are not duplicative, and that any information from the examination, testing, and inspections is considered in making risk-based determinations, including the establishment of inspection priorities. The MOU between FSIS and FDA was signed on April 30, 2014, and can be found on the FSIS Web site at http://www.fsis.usda.gov/wps/portal/informational/aboutfsis/food-safety-agencies/mou . This final rule issues regulations in response to the 2014 Farm Bill mandate. In addition, this final rule includes a summary of the major issues raised by comments to the 2011 proposed rule and FSIS's responses to the comments, including changes made to the proposed regulations in response to comments. IV. Use of the Terms “Catfish” and “Fish” in Preamble Discussion For purposes of convenience, the preamble discussion in this final rule will use the terms “catfish” and “catfish products” where appropriate when discussing and referencing the 2011 Proposed Rule, since those terms were used in the proposal. The preamble discussion of the final rule amendments will use the terms “fish of the order Siluriformes”, “Siluriformes fish,” or “fish.” V. Scientific Classification (Taxonomy) of the Catfishes As discussed in the proposed rule (76 FR 10435), in the taxonomy of the fishes, fish of the order Siluriformes include the Ictaluridae, the North American catfish, to which family belong the fork-tailed channel catfish ( Ictalurus punctatus ) and blue catfish ( I. furcatus ), the principal United States farm-raised species, and the flathead catfish ( Pylodictis olivaris ). Other species in the United States that are in the Ictaluridae family are the white catfish ( Ameiurus catus, synonym I. catus ), and the black, brown, and yellow bullhead ( A. melas, syn. I. melas, A. nebulosus, syn. I. nebulosus, and A. natalis, syn. I. natalis ). Also among the Siluriformes are the air-breathing catfishes of the Clariidae family, to which belongs Clarias fuscus, a species raised in the United States on a small scale in Hawaii. Another family of Siluriformes, the Pangasiidae, the so-called “giant catfishes,” 2 includes the aquaculture species basa ( Pangasius bocourti ) and tra or swai ( Pangasius hypophthalmus; syn., Pangasius sutchi ), raised principally in Southeast Asia for domestic consumption and export. Other Siluriformes fish species raised in Asia include the hybrid Clarias macrocephalus and North American channel catfish ( I. punctatus ) that are raised for export to the United States. 2 Integrated Taxonomic Information System (ITIS) report on “Siluriformes.” At http://www.itis.gov . VI. Current Inspection of Domestic and Imported Fish As discussed in the proposed rule, U.S. catfish processors, exporters, and importers have been subject to the U.S. Food and Drug Administration's (FDA) seafood Hazard Analysis Critical Control Point (HACCP) regulations (21 CFR 123) and to other requirements under the Food, Drug, and Cosmetic (FD&C) Act (76 FR 10437). FDA's regulations on current good manufacturing practices (cGMPs, at 21 CFR 110) and on recordkeeping and registration requirements (21 CFR part 1, subparts H and J) also apply to those establishments. For imported fish and fishery products, FDA requires the importer to either: (1) Obtain fish or fish products from a country that has an active memorandum of understanding with FDA that covers the product and documents the equivalence or compliance of the foreign inspection system with that of the United States, or (2) have and implement written verification procedures for ensuring fish and fish products offered for import into the United States were processed in accordance with FDA regulations in 21 CFR part 123 (21 CFR 123.12). In addition to the FDA regulations, some United States catfish processing establishments contract for voluntary, fee-for-service inspection and certification programs administered by the Department of Commerce's National Marine Fisheries Service (NMFS) under the Agricultural Marketing Act (7 U.S.C. 1622, 1624) and implementing regulations (50 CFR part 260). NMFS administers three levels of seafood inspection programs under authority of the Agricultural Marketing Act (7 U.S.C. 1622, 1624) and regulations implementing that act (50 CFR part 260). The three levels are: (1) A resident inspection program, which provides inspection to qualifying establishments; (2) an integrated quality assurance program, under which an establishment operates an NMFS-approved quality assurance system and assists NMFS personnel in carrying out U.S. grading or specification regulations; and (3) a HACCP-Quality Management Program (QMP), under which the establishment's quality assurance program is enhanced to meet the ISO 9001 quality management standards. VII. Public Health Considerations: Potential Chemical and Microbiological Contaminants As discussed in the proposed rule, because catfish of domestic or foreign origin may be exposed to chemical and microbiological contaminants, FSIS considered the food safety issues that might be presented by catfish in planning its regulatory approach (76 FR 10438). In the Hazard Identification section of its risk assessment, Assessment of the Potential Change in Human Health Risk Associated with Applying Inspection to Fish of the Order Siluriformes, the Agency discussed the three main classes of chemical residues identified in some domestic and foreign catfish—heavy metals, pesticides, and antimicrobials and the adverse health effects that have been associated with those chemicals. The assessment also summarized the results of FSIS, Agriculture Marketing Service (AMS) and FDA testing of the fish for these residues (76 FR 10438). The test results showed that, while catfish may not frequently harbor residues of illegal drugs or violative concentrations of other chemicals, the potential exists for such contamination. For example, 9% and 2% of imported catfish tested for malachite green and gentian violet, respectively, tested positive for those banned chemicals. Because some shipments of imported catfish have been found with residues of drugs that FDA has banned and that are unsafe, FSIS proposed to conduct regular residue sampling, as it does for imported meat products, to ensure the safety of imported catfish products (9 CFR 557.6(a)(3)). For microbial pathogens in catfish, the hazard identification component of the FSIS catfish risk assessment 3 identified certain microorganisms as higher-priority. The prioritization was based on association with catfish-related outbreaks and on the severity of resultant illness. The microorganisms identified included Salmonella, Listeria monocytogenes, and Enterotoxigenic E. coli (76 FR 10439). 3 U.S. Department of Agriculture. Food Safety and Inspection Service. Office of Public Health Science. December 2010. Draft Risk Assessment of the Potential Human Health Effect of Applying Continuous Inspection to Catfish. Washington, DC (as referenced in the proposed rule). FSIS conducted an assessment of the potential risk to human health from consumption of fish of the order Siluriformes, using the example of Salmonella contamination. The Agency was particularly interested in Salmonella because the bacteria are the most frequently reported cause of foodborne illness in the United States. From a public health perspective, even a small decrease in the percentage of an illness that affects a large number of people can have a substantial effect of decreasing illness, and thus, improve public health. According to the Centers for Disease Control and Prevention (CDC), salmonellosis causes an estimated 1.4 million cases of foodborne illness and more than 400 deaths annually in the United States. 4 In addition, CDC lists catfish as the vehicle in at least one outbreak of human salmonellosis may have been related to catfish consumption. 5 Salmonella is a useful model because its presence provides an indication of the sanitary conditions under which food is produced and, if considering illnesses rather than raw product, the way it is prepared. In addition, an approach that produces a reduction in Salmonella through improved process control can be effective in controlling for the presence of other microbial pathogens. 6 4 Scallan, et al. Emerging Infectious Diseases, Vol. 17, No. 1. January 2011. 5 U.S. Department of Agriculture. Food Safety and Inspection Service. Office of Public Health Science. December 2010. Draft Risk Assessment of the Potential Human Health Effect of Applying Continuous Inspection to Catfish. Washington, DC (as referenced in the proposed rule). 6 Food Safety and Inspection Service. 2006. Review of the Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems Final Rule pursuant to Section 610 of the Regulatory Flexibility Act, as Amended. Available at: http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/2007-0022P/610_Report_PR_HACCP.pdf . FSIS invited all interested stakeholders to submit additional data and scientific evidence specific to catfish food safety. USDA also sought public comment on the evidence regarding the public health benefits and cost-effectiveness to be achieved with the proposed program (76 FR 10440). FSIS received comments on these issues and its responses are included in Comments and Responses (Section XI), below. The FSIS risk assessment has been modified to move the hazard identification section to the body of the risk assessment document. In addition, an Addendum has been added to the risk assessment, which: (1) Summarizes potentially relevant research studies published since the draft risk assessment was conducted; (2) provides an update from CDC's outbreak database, stating that it does not indicate that any additional outbreaks have occurred recently; and (3) updates data on the results of analyses of pesticides from the Agricultural Marketing Service's Pesticide Data Program. The updated risk assessment (December 2014) is posted on the FSIS Web site at: http://www.fsis.usda.gov/wps/wcm/connect/63387be5-ca8e-442d-b047-f031f29a8a47/Silurifomes-RA.pdf?MOD=AJPERES VIII. Summary of Proposed and Final Regulatory Requirements FSIS proposed regulatory requirements for the inspection of catfish and catfish products adapted from the appropriate meat inspection regulations that prevent the transportation, sale, offer for sale or transportation, or receipt for transportation, in commerce, of adulterated or misbranded products (21 U.S.C. 602, 610, 621). Because there are differences between fish and “meat” (cattle, sheep, swine, goats, horses, mules or other equines), FSIS proposed some separate regulations for catfish establishments and products. In many cases, FSIS proposed to reference the existing regulations for meat and meat food products as applying to catfish. A. Organization of Inspection Operations In general, the proposed regulations paralleled the sequence of operations from the harvesting and delivery of the fish to the processing plant, through the in-plant operations, to transportation in commerce, specifying export and import requirements where appropriate. After outlining the district-level supervision of the inspection in proposed 9 CFR 530.2, FSIS made it clear in proposed 9 CFR 530.3, that, as provided in 9 CFR 300.6, persons that are subject to the FMIA, as specifically the catfish inspection provisions, are to grant authorized Agency or Department personnel access to establishments that process catfish and to other establishments in industries related to the catfish processing industry (for example, fish farms, fish hatcheries, fish feed mills, live-fish catchers/loaders and haulers, distributors, and brokers) (76 FR 10440). FSIS did not make any changes in the final regulations to the inspection operations provisions or to the access Agency or Department personnel have to establishments. B. Definitions In proposed 9 CFR part 531, FSIS used the same definitions for the catfish inspection regulations as the meat inspection regulations (9 CFR 301.2). The Agency proposed to add definitions for “catfish,” “catfish byproduct,” “catfish food product,” “catfish product,” “farm-raised,” and some other terms (76 FR 10441). The ante-mortem inspection, post-mortem inspection, and humane slaughter provisions of the amended FMIA do not apply to catfish, therefore, the Agency did not propose definitions for slaughtering methods. FSIS specifically requested comment on whether the term “slaughter” should be defined. The Agency received comments on some of the proposed regulatory definitions but, as explained in the Comments and Responses (Section XI) below, determined that it was not necessary to make changes to these definitions. The Agency received numerous comments on the “catfish” species definition. However, as provided by the 2014 Farm Bill, FSIS has jurisdiction over all fish of the order Siluriformes. In this final rule, 9 CFR part 531 has been amended to delete the term “catfish,” and its definition, and replace it with “fish,” defined as “any fish of the order Siluriformes, whether live or dead.” C. Establishments Requiring Inspection; Grant and Approval of Inspection In proposed 9 CFR part 532, FSIS identified the classes of catfish establishments that require inspection and outlined the requirements to qualify for a grant of inspection and the application procedures. FSIS also cross-referenced 9 CFR parts 305 and 306, on the assignment of establishment numbers and the assignment and authorities of FSIS personnel. As discussed in the proposed rule, the amended FMIA did not provide an exemption from inspection for custom catfish slaughter and processing facilities. FSIS did however, propose to provide an exemption for retail stores and restaurants in proposed 9 CFR 532.3 (under 21 U.S.C. 661(c)(2), that parallels 9 CFR 303.1(d) and (e). FSIS also proposed exemptions for individual household (single-sale) purchases and non-household consumers based on the poultry exemptions in 9 CFR 381.10. FSIS solicited comment on the limits on retail sales to household or non-household consumers. In proposed 9 CFR 532.4, the Agency asserted Federal pre-emption of State or local authority with respect to premises, facilities, and operations at an official establishment and with respect to labeling, packaging, and ingredient requirements in proposed 9 CFR 532.4. In addition, the Agency proposed in 9 CFR 532.5 to exempt from inspection articles that do not contain a minimum amount of catfish (3 percent raw or 2 percent cooked catfish) or are historically not regarded by consumers as products of the catfish food products industry. FSIS received a comment on the proposed limits on retail sales, discussed in Comments and Responses (Section XI) below. The Agency did not make any changes to the purchase quantity limits in the final regulations. However, in response to a comment on exemptions, the Agency has added language (in 9 CFR 532.3) defining as an exempt retail operation, the slaughter, by the operator of a retail store or restaurant, of live fish purchased by a consumer at the retail store or restaurant for the consumer and at the consumer's instructions. D. Facility Requirements for Inspection In proposed 9 CFR part 533, FSIS set forth facility requirements for catfish processing establishments. The regulations proposed requirements for office space and furnishings for program employees, sufficient lighting for the proper conduct of inspection, facilities for performing inspection, receptacles for diseased carcasses and parts, and materials for cleansing and disinfecting hands, for sterilizing instruments used in handling diseased carcasses, and for cleaning and sanitizing floors and other articles or places contaminated by diseased carcasses. FSIS also proposed that establishments have to provide adequate facilities for the receipt and inspection of catfish and catfish products. The final regulations are consistent with those proposed. Under this final rule, FSIS will approve operating schedules for fish establishments (9 CFR 533.5) just as it does for official meat establishments. FSIS received comments on schedule of operations and addressed the comments in the Comments and Responses (Section XI), below. The final regulations are consistent with those proposed. E. Pre-Harvest and Transport To Processing Establishment In proposed 9 CFR part 534, FSIS outlined the pre-harvest standards to be applied to catfish to ensure that the environmental conditions and source waters in which the catfish are grown will not render them unfit for food. FSIS also proposed general standards for the transportation of catfish to the processing plant. As discussed below, FSIS received comments on pre-harvest and transport issues and is clarifying comments raised in the responses to comments section below. However, the final provisions are consistent with those proposed. F. Sanitation and Hazard Analysis and Critical Control Point (HACCP) System Requirements for Processing Facilities In proposed 9 CFR part 537, FSIS proposed to require that any official establishment that prepares or processes catfish or catfish products for human food comply with all of the sanitation requirements in 9 CFR part 416 and the HACCP requirements in 9 CFR part 417. In this final rule, FSIS is adopting 9 CFR part 537, which requires Siluriformes fish establishments to comply with the HACCP and sanitation requirements. G. Mandatory Dispositions; Performance Standards Respecting Physical, Chemical, or Biological Contaminants In proposed 9 CFR part 539, FSIS listed the diseases or other conditions that would lead to condemnation of catfish carcasses or parts affected upon inspection. FSIS requested comment on the extent to which infection should result in condemnation and on whether there are other conditions found in catfish that require such disposition. FSIS received general comments to the effect that diseases should not automatically render catfish adulterated as discussed in Comments and Responses (Section XI) below. FSIS has not changed the proposed regulations in response to these comments. However, in section 539, for greater precision than in the proposed rule, FSIS is stating that “unusual gross deformities caused by disease or chemical contamination” may not be used for human food. H. Handling and Disposal of Condemned and Inedible Materials In 9 CFR part 540, FSIS proposed to require that a processor prevent catfish that have died otherwise than by slaughter from entering the official establishment. FSIS explained (in proposed 9 CFR 540.1(b)) that the establishment would have to maintain physical separation between slaughtered catfish and those that died otherwise than by slaughter to prevent commingling of edible and inedible product (76 FR 10444). In addition, FSIS explained that all condemned or otherwise inedible catfish parts would have to be conveyed from the official premises for further disposition at a rendering plant or other facility that handles inedible products. FSIS received some comments on these requirements, as discussed in Comments and Responses (Section XI) below; however, the Agency did not change the proposed provisions in response to the comments. I. Marks, Marking, and Labeling of Products and Containers 1. Official Marks and Devices FSIS proposed to use certain official marks, devices, and certificates for the purpose of identifying inspected and passed catfish and catfish products and their status (9 CFR 541.1 through 541.5). The Agency proposed in 9 CFR 541.2(a) to provide for an official inspection legend containing the number of the official establishment, and that the form of the official inspection legend will be that for meat products (9 CFR 312.2(b)(1)), or another form that the Agency would prescribe. FSIS requested comments and suggestions on alternative forms. There were no comments on the form of the official inspection legend. Therefore, the Agency is requiring 9 CFR 541.1 that the official inspection legend for fish and fish products be in the form of the meat products inspection legend (9 CFR 312.12) or another form determined by the Administrator to provide flexibility for future innovations in marking of product. FSIS proposed to require that whole, gutted catfish carcasses, inspected and passed at an official establishment and intended for sale as whole, gutted catfish, be marked or labeled with the official inspection legend containing the number of the establishment at the time of inspection (9 CFR 541.2(d)). The Agency requested comment on whether the marking is necessary, the form of the mark that would be satisfactory, and how the mark should be applied. FSIS received comments that applying the mark of inspection to all carcasses of whole, gutted fish may be impractical because of the size of the product. As discussed in the Comments and Responses (Section XI) below, the Agency recognizes that it may be impractical to physically apply the inspection legend to whole, gutted fish carcasses. Therefore, in this final rule, 9 CFR 541.2(d) provides that whole, gutted fish carcasses that have been inspected and passed at an official establishment, and that are intended for sale as whole, gutted catfish, must be stamped with the official inspection legend or properly packaged in an immediate container labeled with the official inspection legend, as well as all other required labeling features. All other official marks and devices labeling regulations (9 CFR 541.1 through 541.5) are finalized without change. 2. Labeling Requirements; Prior Approval of Labeling The Agency proposed (9 CFR 541.7) to apply to catfish and catfish products many of the general meat labeling and label approval requirements in 9 CFR part 317, subpart A. The proposed labeling regulations govern labels and labeling, safe-handling labeling, abbreviations of official marks, labeling approval, generically approved labeling, the use of approved labels, the labeling of products for foreign commerce, prohibited practices, the reuse of official inspection marks, filling of containers, relabeling of products, the storage and distribution of labels, and the requirements for packaging materials. In the proposed rule, the Agency specifically noted that processors of catfish and catfish products will be able to use generically approved labeling if it meets the generic labeling requirements in 9 CFR 317.5 (76 FR 10445). As discussed in the Comments and Responses (Section XI) below, the final provisions in 9 CFR 541.7 include a paragraph (c), which modifies the safe handling instructions to make the rationale statement read, “This product was prepared from inspected and passed fish,” and the labeling statements read, “Keep raw fish from other foods. Wash working surfaces (including cutting boards), utensils, and hands after touching raw fish.” In addition, on November 7, 2013, FSIS published the final rule, “Prior Label Approval System: Generic Label Approval” (78 FR 66826). In that final rule, the Agency consolidated the meat and poultry label approval regulations into a new part, 9 CFR part 412, Label Approval. Therefore, in this final rule, 9 CFR 541.7 includes a paragraph (g) that references 9 CFR 412 for label approval. This rule adopts the other proposed labeling and label approval regulations in 9 CFR 541.7 without change. 3. Prevention of False or Misleading Labeling Practices In the preamble of the proposed rule (76 FR 10445), FSIS explained that under its regulations, no product or any of its wrappers, packaging, or other containers may bear any false or misleading marking, label, or other labeling, and no statement, work picture, design, or device that conveys any false impression or gives any false indication of origin or quality or that is otherwise false or misleading may appear in any marking or other labeling. In addition, no product may be enclosed wholly or partly in any wrapper, packaging, or other container that is made, formed, or filled in a manner that would make it misleading (9 CFR 317.8). The Agency explained that to prevent the misuse of labeling, FSIS enforces regulations controlling the conditions under which product may be relabeled at a location other than an official establishment (9 CFR 317.12). The Agency also regulates the conditions under which labels, wrappers, or containers bearing official marks may be transported from one official establishment to another official establishment (9 CFR 317.13). FSIS proposed that all these requirements, which apply to meat and meat food products, would apply to catfish and catfish products under the proposed rule (9 CFR 541.7(a)). In the preamble discussion on preventing false or misleading labeling practices, the Agency stated that, after a fish is processed, it is a major challenge for regulators and industry to visually identify the species of fish (76 FR 10445). Because of the interest of the catfish products industry and consumers in ensuring that product labeling correctly represents the actual species of fish in the product, FSIS was considering various technological means to verify catfish species. The Agency requested comment and suggestions on species verification methods that the Agency might use. The Agency received several comments on the methods of speciation and country of origin labeling. The responses to these comments are discussed in the Comments and Responses (Section XI) below. This rule finalizes the prevention of false or misleading labeling regulations in 9 CFR 541.7(a) (consistent with 9 CFR 317.8, 317.12, and 317.13 specifically) and adds 9 CFR 541.7(b) to correct the reference to the AMS regulations for the country of origin labeling for fish (7 CFR, part 60, subpart A). In addition, under the Federal Food, Drug, and Cosmetic (FD&C) Act (21 U.S.C. 321d (a)), the term “catfish” may only be considered to be a common or usual name (or part thereof) for fish classified within the family Ictaluridae; and only labeling or advertising for fish classified within that family may include the term “catfish.” Also, a food is misbranded if it purports to be or is represented as catfish, unless it is fish classified within the family Ictaluridae (21 U.S.C. 343(t)). Therefore, in this final rule, FSIS has revised proposed 9 CFR 541.7 to require that the term “catfish” be used only on labels and in labeling of fish within the family Ictaluridae and the products of those fish. The Agency is also requiring in 9 CFR 541.7 that fish and fish products in all other families in the order Siluriformes be labeled with appropriate common or usual names. Domestic and foreign fish establishments should consult FDA's “Guidance for Industry: The Seafood List—FDA's Guide to Acceptable Market Names for Seafood Sold in Interstate Commerce,” for appropriate common or usual names ( http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/seafood/ucm113260.htm . 4. Net Weight and Retained Water As discussed in the preamble, FSIS's labeling regulations on net weight of meat products incorporates by reference the National Institute of Standards and Technology's (NIST) Handbook 133 (76 FR 10445). The Agency also explained that the net weight of catfish presents a specific challenge because of the frequent and varying use of ice-glazing to preserve the freshness of the product (76 FR 10445). The Agency proposed that packages of fresh or fresh-frozen catfish or parts must be labeled to reflect 100-percent net weight after thawing (9 CFR 541.7(b)(1)). To regulate the net weight for raw catfish products, FSIS proposed in 9 CFR 541.7(b) to apply the requirements for control of retained water from processing in raw meat and poultry products through 9 CFR part 441. Retained water—water remaining in raw product after it undergoes immersion chilling or a similar process—would not be permitted unless the official establishment could show that the retained water is an unavoidable consequence of the process (9 CFR 441.10(a)). The establishment would have to label its product to state the maximum percentage of retained water. In response to comment, discussed further in Comments and Responses (Section XI) below, the Agency is clarifying that, according to NIST Handbook 133 net weight test procedures for ice-glazed fish products are “deglazed” by placing the product under a gentle spray of cold water, and the product should remain rigid. However, as proposed, the NIST Handbook 133, net weight test procedures for frozen or fresh-frozen fish are determined on a thawed basis. The proposed net weight and retained water labeling regulations in 9 CFR 541.7 are adopted without change. 5. Nutrition Labeling Requirements In 9 CFR 541.7(c), the Agency proposed, under the FMIA (21 U.S.C. 601(n)(1), 621) to apply the nutrition labeling requirements to catfish and catfish products that are not raw, single-ingredient products. The Agency received no comments on this provision, and it is adopted as proposed. J. Food Ingredients Permitted FSIS proposed in 9 CFR part 544 to apply to catfish products the requirements in 9 CFR part 424 prohibiting a product from bearing or containing any food ingredient that would render it adulterated or misbranded. As discussed in the proposed rule, FSIS will make determinations on the safety and suitability of uses of food ingredients for Siluriformes products in consultation with FDA, as it does for all food ingredients (76 FR 10446). FSIS compiles safe and suitable uses, including limits and conditions of use, of food ingredients in these products and makes the information available in an instruction to its inspection force in FSIS Directive 7120.1. This directive is regularly updated and published on the Agency's Web site at: http://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/directives/7000-series . This final rule adopts the requirement as proposed. K. Ready-to-Eat and Canned Fish Products: Control of Listeria monocytogenes As discussed in the proposed rule (76 FR 10446), ready-to-eat (RTE) catfish products, such as smoked catfish, would have to comply with appropriate performance standards if they are not to be considered adulterated under the FMIA (21 U.S.C. 601(m)). FSIS proposed to make post-lethality-exposed catfish products subject to the requirements in 9 CFR part 430 (proposed 9 CFR 548.6). An RTE catfish product would be considered adulterated if it contains L. monocytogenes, or if it comes into direct contact with a food-contact surface that is contaminated with L. monocytogenes because it is likely to be consumed without further processing, such as cooking. The Agency is adopting this provision as proposed. L. Canned Products As discussed in the proposed rule, FSIS is not aware of any canned catfish products processed in the U.S., but canned catfish soups are imported into this country (76 FR 10446). FSIS proposed (9 CFR 548.6) that any domestic canned catfish products that an official establishment manufactures will be subject to requirements similar to those for canning and canned meat products (9 CFR 318.300-318.311). As explained in the proposed rule, imported canned catfish products would have to be prepared under requirements that are equivalent to those applying to domestic products. FSIS is adopting this provision as proposed. M. Accredited Laboratories FSIS proposed that catfish processing establishments, like other official establishments, may use a non-Federal analytical laboratory that meets the accreditation requirements in 9 CFR 439 instead of an FSIS laboratory to analyze official regulatory samples (proposed 9 CFR 548.9). The Agency is adopting proposed 9 CFR 548.9 as final, without changes. N. Standards of Identity and Composition In the preamble to the proposed rule, FSIS requested comment on whether the Agency should promulgate any standards of identity or composition for catfish products (76 FR 10446). The Agency received comments on catfish standards of identity, as discussed in Comments and Responses (Section XI) below, but is not promulgating standards of identity or composition in this final rule. O. Exports The Agency proposed (9 CFR part 552) to adopt requirements for exported catfish and catfish products that are similar to those that apply to meat articles by cross-referencing the provision of 9 CFR part 322. There are no changes to the proposed regulations in this final rule. P. Transportation in Commerce FSIS proposed in 9 CFR 555.1 to require that any catfish product capable of use as human food that is to be transported in commerce be properly handled and maintained to ensure that it is not adulterated and is properly marked and labeled. As discussed in the proposed rule, a transport conveyance intended to carry catfish products would be subject to FSIS inspection to determine its sanitary condition (76 FR 10447). FSIS also explained that products on an insanitary vehicle would have to be removed and either handled in accordance with the regulations on mandatory dispositions or on the handling of condemned and inedible materials (9 CFR part 539 or part 540). The Agency also discussed that it had tentatively determined that other regulations on the transportation of meat and meat food products (in 9 CFR part 325) are appropriate for the transportation of catfish products (9 CFR 555.3-555.8). The proposed regulations addressed the transportation of unmarked inspected product under FSIS affixed-seal; product that may have become adulterated in transit or storage; inedible products; the filing of original certificates for unmarked inspected products; and the unloading of any catfish product from an officially sealed conveyance or loading after the conveyance has left the official establishment. The Agency is adopting these proposed regulations as final. Q. Imported Products As FSIS discussed in the proposed rule, under the FMIA, the provisions of the act governing imports apply to catfish and catfish products (76 FR 10447). FSIS proposed to apply the requirements for the inspection of imported meat products to imported catfish products (9 CFR part 557, referencing 9 CFR part 327). Under the proposed rule and final rule, FSIS would have to find that the system of fish inspection maintained by any foreign country, with respect to establishments preparing products in such country for export to the United States, insures compliance of the establishments and their products with requirements equivalent to the inspection and other requirements of the FMIA and the regulations that implement it in the United States. When the Agency determines that a foreign country's inspection system for fish is equivalent to that operated by FSIS, the Agency would publish a proposed rule to list the country in the regulations as eligible to export Siluriformes fish and fish products to the U.S., and would provide an opportunity for public comment. Should the Agency decide to list the country's system as equivalent, FSIS would respond to comments in the final rule and list the name of the country in the regulations (9 CFR 557.2(b)). FSIS is adopting these proposed requirements as final, except for terminology changes to reflect that they apply to fish in the order Siluriformes. On September 19, 2014, FSIS published a final rule (79 FR 56220) amending its regulations for imported meat, poultry, and egg products to provide, among other things, for use of the Agency's electronic Public Health Information System (PHIS) import component. In addition to providing for the PHIS import component, the final rule deleted overly prescriptive formatting and narrative requirements for foreign establishments and inspection certificates, required additional information on the certificates, and made the requirements the same for imported meat, poultry, and egg products. The regulations in 9 CFR part 557 adopted by this final rule on Siluriformes inspection reflect the amendments to accommodate the use of PHIS. R. Demonstrating Equivalence of Foreign Systems FSIS proposed that countries will need to demonstrate that their inspection systems are equivalent to the U.S. system in the following respects: (1) Program administration. Under proposed 9 CFR 557.2 (referencing 9 CFR 327.2) the foreign program for catfish would have to be staffed in a way that will ensure uniform enforcement of the laws and regulations. Ultimate control and supervision must rest with the national government (9 CFR 327.2(a)(2)(i)(B)). Qualified, competent inspection personnel must be employed in the food safety system (9 CFR 327.2(a)(2)(i)(C)). National inspection officials would have to have the authority to enforce requisite laws and regulations and certify or refuse to certify products intended for export (9 CFR 327.2(a)(2)(i)(D)). There would have to be adequate administrative and technical support and inspection, sanitation, quality, species verification, residue standards, and other regulatory requirements that are equivalent to those of the United States (9 CFR 327.2(a)(2)(i)(E)-(G)). FSIS is adopting these requirements as proposed. (2) Legal authority and requirements governing catfish and catfish products inspection. Under proposed 9 CFR 557.3, to be considered eligible to export catfish products to the United States, foreign countries would have to enforce laws and regulations that address the conditions under which catfish are raised and transported to the processing establishment (9 CFR 327.2(a)(2)(ii)(I)). In countries where catfish producers use floating cages on rivers and “raceway ponds” that are filled and emptied by the continuous flow of water from nearby rivers, under the proposed rule, the water quality, residue, and other standards would have to be equivalent to those applying to catfish raised in the United States. Also, under the proposed rule, eligible foreign countries would have to establish standards for, and maintain official supervision of, preparation and processing of product to ensure that adulterated or misbranded product is not prepared for export to the United States (9 CFR 327.2(a)(ii)(D)). A single standard of inspection and sanitation would need to be maintained throughout all certified establishments (9 CFR 327.2(a)(ii)(E)). The country's requirements would need to address sanitary handling of product and provide for official controls over condemned material; a HACCP system equivalent to that set forth in 9 CFR part 417; and other applicable controls under the FMIA or implementing regulations (9 CFR 327.2(a)(ii)(F)-(I)). (3) Document evaluation and system review. Under the proposed rule, foreign countries seeking eligibility to export catfish and catfish products into the United States (9 CFR 557.2(a)) would also have to present to FSIS copies of laws, regulations, and other information pertaining to their system of catfish product inspection, just as countries now do when they seek eligibility to export products of other species amenable to the FMIA. FSIS estimates that it would take approximately 3 months per submission to evaluate this documentation. FSIS would determine eligibility on the basis of a study of these documents and an on-site visit to the country of the system in operation by FSIS. FSIS would also conduct periodic reviews of foreign catfish products inspection systems to determine their continued eligibility (9 CFR 327.2(a)(3)). (4) Maintenance of standards. In addition, countries that FSIS eventually determines to be eligible to export catfish and catfish products into the United States would have to provide for periodic visits to certified establishments to ensure that U.S. requirements are being met and for written reports on the supervisory visits (proposed 9 CFR 557.2, under 21 U.S.C. 620). The reports would have to be available to FSIS. The foreign program would have to conduct random sampling of catfish tissues and the testing of the tissues for residues identified by FSIS or by the foreign inspection authority as potential contaminants, in accordance with sampling and analytical techniques approved by FSIS (9 CFR 327.2(a)(2)(iv)(C)). The residue testing would have to be conducted on samples from catfish intended for export to the United States. Once FSIS has determined that countries maintain equivalent inspection systems, only certified foreign catfish establishments, that is, establishments that foreign program officials have certified as complying with the requirements equivalent to United States requirements, would be eligible to export their catfish products to the United States. If FSIS found that a foreign establishment is not in compliance with United States requirements for imported products, FSIS would terminate the eligibility of the establishment. FSIS would provide reasonable notice to the foreign government of the proposed termination of eligibility, unless delay in notification could result in the importation of adulterated or misbranded product (9 CFR 327.2(a)(3)). This final rule adopts these proposed regulations without change. However, to provide foreign countries with adequate time to transition to the final regulations, on the date that the rule becomes effective, March 1, 2016, foreign countries seeking to continue exporting Siluriformes fish and fish products to the United States during the 18-month transitional period are permitted to do so, provided they submit (1) the list of establishments (with the establishment name and number) currently exporting Siluriformes fish and fish products to the United States and (2) adequate documentation demonstrating that the foreign country currently has laws or other legal measures in place that provide authority to regulate the growing and processing of fish for human food and to assure compliance with the Food and Drug Administration's (FDA) regulatory requirements in 21 CFR part 123, Fish and Fishery Products, which include requirements for good manufacturing practices, Hazard analysis and Hazard Analysis Critical Control Point (HACCP) plans, and sanitation control procedures. This initial documentation will not be used to establish equivalency. By the end of the 18-month transitional period, foreign countries seeking equivalency must submit documentation showing that they have systems for inspection of Siluriformes fish and fish products equivalent to FSIS's system. A country can continue to export fish products to the United States after the 18-month transitional period, if the country has submitted its documentation on equivalency by the start of full enforcement of this rule, September 1, 2017. See Section XII., “FSIS Implemention,” for more details. S. Marking and Labeling of Imported Products The proposed regulations (9 CFR 557.14 and 557.15) reference the meat regulations (9 CFR 327.14 and 327.15) requiring the marking and labeling of immediate and outside containers of imported catfish and catfish products. There are no changes to these proposed regulations in this final rule. IX. Proposed Regulations Under Other FMIA Subchapters A. Rules of Practice; Reference to Rules of Practice FSIS proposed to apply its rules of practice (9 CFR part 500) in enforcing the proposed catfish inspection regulations (proposed 9 CFR 561.1). Also, FSIS proposed to provide establishments with an opportunity for presentation of views (proposed 9 CFR 561.2, referencing 9 CFR part 335) before reporting violations to the Department of Justice for criminal prosecution. The procedure to be followed in a case relating to catfish and catfish products inspection would be the same as that followed in a case relating to meat and meat food products inspection. FSIS uses its rules of practice for enforcement processes that may lead to such actions as withholding (refusing to allow the mark of inspection to be applied to product) or suspension (withdrawing inspection program employees from a facility) of inspection. There are no changes to the proposed regulations in this final rule. B. Detention, and Seizure and Condemnation 1. Detention FSIS proposed to exercise its detention authority under the FMIA upon finding that catfish or catfish products in commerce are adulterated, misbranded, or otherwise in violation of the Act or regulatory requirements (proposed 9 CFR 559.1, referencing 9 CFR 329.1-329.6). This final rule adopts these proposed regulations without change. 2. Seizure and Condemnation FSIS proposed to apply the provisions for seizure and condemnation in the meat regulations (9 CFR 329.7-329.9) to catfish (proposed 9 CFR 559.2). The regulations also address criminal offenses addressed in Sections 22 and 405 of the FMIA (21 U.S.C. 622, 675), such as bribery of Program employees, receipt of gifts by Program employees, and assaults on, or other interference with, Program employees while engaged in, or on account of, the performance of their official duties under the Act. There are no changes to the proposed regulations in this final rule. X. Records Required To Be Kept In proposed 9 CFR part 550, FSIS proposed to require persons and firms involved in processing, buying and selling, or rendering catfish or catfish products to keep records on their activities respecting catfish sold, transported, or offered for sale or transport, in commerce. The records they would be required to keep include sales records or invoices, shippers' certificates and required permits, records of seal numbers used in the sealed transport of inedible products, guaranties provided by suppliers of packaging materials, canning records as required by 9 CFR part 318, subpart G, nutrition labeling records, and records of all labeling, along with the formulation and processing procedures. In addition, the Agency proposed that persons and firms covered by the recordkeeping requirements would have to register with the FSIS Administrator, and asked for comment on a proposed time frame for completing this registration (76 FR 10449). FSIS also stated that it would require each official establishment to provide accurate information to FSIS employees so that they could report on the amount of products prepared or handled in the establishment, and on sanitation, microbiological testing, and other aspects of the establishment's operations (76 FR 10449). The Agency proposed that the operator of each establishment report quarterly on the number of pounds of catfish processed. The report has to be filed within 15 days after the end of each quarter. The establishment operator would also have to file other reports as FSIS might require from time to time under the FMIA (9 CFR 550.6). In addition, FSIS proposed to require that a consignee who refuses to accept delivery of a product bearing the mark of inspection because it is adulterated or misbranded notify the Inspector-in-Charge of the kind, quantity, source, and present location of the product (9 CFR 550.7). There are no changes to the proposed regulations in this final rule. XI. Comments and Responses FSIS received approximately 4,335 comments on the proposed rule. About 4,000 of the comments were form letters submitted as part of a write-in campaign initiated by a consumer advocacy organization. FSIS also received a separate petition signed by 41 private citizens, and a joint submission from 16 food and agricultural organizations and companies. Almost all of the remaining comments were from private citizens; domestic and foreign catfish farmers; trade groups and associations representing the catfish and seafood industry (processing, manufacturing, storage, and distribution); the catfish processing industry; consumer advocacy groups; members of U.S. Congress; foreign government ministries of agriculture and rural development; foreign chambers of commerce; trade associations representing retail and restaurant industries; aquaculture industry advocacy associations; public policy organizations; U.S. State and county officials; aquaculture scientists; members of academia; restaurant consortiums; a foreign government; an organization of U.S. regulatory officials; and a small business advocacy association. The Agency's responses to comments on major issues concerning the proposed rule are discussed below. A. General Opposition Comment: Some comments opposed the transfer of jurisdiction over catfish and catfish products to FSIS for a variety of reasons. The comments generally expressed the concern that the proposal was unnecessary, wasteful, unjustified, or redundant. Several commenters stated that both FDA and FSIS will regulate the same product. Many commenters also stated that FDA's current regulatory approach ensures the safety of domestically produced and imported seafood products, and that the catfish industry has a demonstrated track record of food safety. Response: Under the 2008 Farm Bill, FSIS was required to develop regulations, in consultation with FDA, to implement FSIS inspection of “catfish,” as defined by its regulations. Under the 2014 Farm Bill, which amended the 2008 Farm Bill, all fish of the order Siluriformes are amenable species under the jurisdiction of FSIS. The 2014 Farm Bill requires FSIS to develop final regulations in consultation with FDA. FSIS consulted FDA during development of these final regulations. The legislation also requires FSIS and FDA to execute a Memorandum of Understanding (MOU) to improve interagency cooperation on food safety and fraud prevention and to maximize the effectiveness of limited personnel and resources. FDA and FSIS have agreed on this MOU. It is posted at http://www.fsis.usda.gov/wps/portal/informational/aboutfsis/food-safety-agencies/mou . B. The Definition of Catfish Comments: Many comments representing domestic groups, individuals, and numerous comments from members of the U.S. Congress, urged FSIS to define catfish as all species in the order Siluriformes, the broader definition. The commenters stated that the broader definition affords the greatest food safety protection for the entire “catfish” category of seafood; it is consistent with the science of taxonomy; and it would include all imported catfish. Foreign governments, foreign ministries of agriculture, foreign catfish farmers, and foreign industries supported defining catfish as only fish of the Ictaluridae family, stating that this definition is the current FDA regulatory definition, adopted by Congress in the 2002 Farm Bill (21 U.S.C. 321d (a)), and that it would provide consistency and eliminate confusion among seafood exporters. Response: The 2014 Farm Bill settled this issue. It amended the FMIA to give FSIS jurisdiction over all establishments that slaughter or process “all fish of the order Siluriformes.” Many Siluriformes fish species are produced in foreign countries and are exported to the United States. To be eligible to be imported into the U.S., these products will have to be produced under inspection systems equivalent to the U.S. system and will be subject to reinspection in the U.S. For labeling or advertising purposes, the FD&C Act provides that the term “catfish” can only be used in labeling of fish classified within the family Ictaluridae. By removing the term “catfish” from the FMIA and using the term “certain fish” in its stead, Congress left FSIS free to use the FD&C Act's definition of “catfish.” Therefore, in this final rule, FSIS is modifying the labeling regulations that it proposed to permit the use of the term “catfish” only on labels of fish from the Ictaluridae family. Siluriformes fish, which includes families in addition to Ictaluridae, will need to be labeled with the appropriate common or usual name. C. Risk Assessment Comments: Many comments asked for additional evidence to support the shift in jurisdiction for catfish and catfish products from FDA to FSIS. The comments also stated that the products of aquaculture are rarely involved in outbreaks of salmonellosis. Comments from a foreign government, a foreign country's chamber of commerce, members of the seafood industry, and trade policy organizations asked FSIS to explain how the proposed rule was consistent with its World Trade Organization's (WTO) Sanitary and Phytosanitary Measures (the “SPS Agreement”) obligations. A domestic catfish processor expressed the need for a risk assessment associated with chemical contamination of catfish aquaculture based on the constantly changing quality of river water. Response: It is important to note that the risk assessment was not conducted “to support the shift in jurisdiction for catfish and catfish products from FDA to FSIS.” FSIS conducted a quantitative food safety risk assessment, in accordance with national and international guidelines, that included all four components of a standard risk assessment: (1) Hazard Identification, (2) Exposure Assessment, (3) Hazard Characterization, and (4) Risk Characterization. FSIS thoroughly reviewed the scientific literature and garnered input from scientists from other Federal agencies and academia in performing the Hazard Identification portion of the risk assessment. The risk assessment was also independently peer-reviewed in accordance with the Office of Management and Budget's Peer Review Guidelines, as required under the Information Quality Act (Pub. L. 106-554). The purpose of the risk assessment was to provide predictions of the public health benefits ( e.g., reduction in foodborne illnesses) that might accompany the implementation of a mandatory inspection system. The risk assessment identified Salmonella as a hazard of primary concern because: (1) It is the foodborne pathogen associated with catfish (McCoy et. al., Journal of Food Protection 74(3):500-16, 2011); (2) there was more available data for assessing the risk of human illnesses associated with Salmonella and assessing the effectiveness of an FSIS regulatory strategy for this hazard; (3) its occurrence in domestic catfish processing facilities and retail catfish is documented; (4) its presence in catfish imported to the United States is documented; and (5) CDC identifies catfish as the vehicle associated with a 1991 outbreak of Salmonella hadar. The estimates for human salmonellosis cases associated with catfish consumed in the United States (under current inspection programs) were supported by an FSIS Risk Assessment and Analytics Staff independent analysis (“attribution analysis”) on the basis of epidemiological data. 7 8 The Centers for Disease Control and Prevention (CDC) concurred with FSIS' findings and stated that FSIS may even have underestimated the number of human salmonellosis cases attributed to catfish by not considering outbreaks attributed to “finfish,” that may have been “catfish.” 7 U.S. Centers for Disease Control and Prevention (CDC). (June 2009) Foodborne Disease Outbreak Surveillance Data. Atlanta, GA. Retrieved from http://www.cdc.gov/foodsafety/fdoss/index.html. 8 Mead, P.S., Slutsker, L., Dietz, V., McCaig, L.F., Bresee, J.S., Shapiro, C., Griffin, P.M., & Tauxe, R.V. (1999). Food-Related Illness and Death in the United States. Emerging Infectious Diseases, 5,607-625. FSIS requirements are consistent with the WTO SPS Agreement on the Application of Sanitary and Phytosanitary Measures. Under the articles of the SPS Agreement, a measure can be taken when it is necessary to protect against a public health hazard and there is scientific support for the measure. Chemical contamination hazards are important to catfish food safety and FSIS anticipates generating chemical contamination data once it begins its inspection program. Any risks identified through FSIS's surveillance will be addressed to ensure food safety. D. Cost and Benefits Analysis Comments: Several comments questioned FSIS's “break-even” analysis in light of the fact that, historically, so few salmonellosis illnesses have been associated with the consumption of contaminated catfish. A member of academia, however, stated that the benefits of implementing this rule would be far greater than those estimated because the calculations did not include the long-term public health benefits of preventing imported product contaminated with chemical residues, such as malachite green, from entering the United States. Other comments stated that the incremental cost increases associated with the rule would negatively affect the marketability of catfish and catfish products. Response: By focusing solely on Salmonella in the risk assessment and the subsequent break-even analysis, FSIS took a conservative approach to estimating the number of illnesses prevented needed to offset costs of implementing this rule. It is possible that the process steps needed to reduce Salmonella on fish will also result in the reduction of other pathogenic microorganisms, such as E. coli (enterohemorrhagic, Shigatoxigenic, enterotoxigenic, and enteropathogenic strains), Listeria monocytogenes, and Clostridium botulinum on raw and ready-to-eat (RTE) fish. Comment: Several comments questioned FSIS's relatively high Agency cost to implement and maintain the proposed mandatory catfish inspection program. Response: In the final rule costs analysis, FSIS lowered its estimated additional net direct costs to implement and continue the mandatory inspection of fish and fish products. These costs are lower than preliminary Regulatory Impact Analysis (RIA) estimates because the domestic fish industry is now more consolidated, contracted, and concentrated and will require fewer additional FSIS resources for inspection. Furthermore, the FSIS Office of Field Operations was recently consolidated and now we will use more of the existing OFO staff (with minimal new hires and relocations) in patrol assignments for the processing-only establishments. This recent consolidation transitioned the Office of Catfish Inspection Programs (OCIP) to OFO. Thus, this transition would eliminate permanent staff positions (such as for managers, supervisors, inspection program personnel, and technical staff) that would have been dedicated to the OCIP, as discussed in the PRIA (scenario 1) of the published Proposed Rule. The Agency cost estimate is in the full RIA of the final rule, in the Appendix material (FRIA Appendix A). Comment: A domestic catfish processor claimed that transferring catfish inspection to FSIS would give processors of all other non-FSIS inspected seafood an unfair cost advantage. Response: FSIS projects in its regulatory impact analysis that the final rule would increase domestic product average net direct cost of aggregate processed fish and fish food products by $0.0008 per pound. According to the USDA, National Agricultural Statistics Service (NASS), the average price received by domestic processors for domestic catfish products was $3.04 per pound in 2013. Thus, FSIS's projected additional net direct cost to the domestic fish processing industry is relatively small when compared to the average domestic price received. Comment: A domestic catfish processor claimed that transferring catfish inspection to FSIS would increase catfish processor's costs. The processor stated that the initial cost to house inspectors and for the industry to conduct laboratory analysis sufficiently rigorous to ensure compliance with FSIS requirements may be significant. In addition, the processor stated that the testing for drugs with sufficient rigor would likely cost several thousand dollars per year. Response: FSIS projected an additional average net direct cost of $0.0008 per pound of aggregated processed fish and fish products to the domestic processors. This additional average net direct cost includes expected capital costs including additional office space for inspectors. Furthermore, the Agency projected additional establishment testing costs for required validation and verification of HACCP processing plans at official establishments. FSIS found on site visits that many domestic processors already have available office space for inspectors. Furthermore, many of these domestic processors already test their fish and fish products for microorganisms and drugs, according to the FDA 2011 Report. Thus, some domestic processors would have little to no additional costs for inspector office space or for microbe and drug testing. The aggregate direct cost FSIS projects for the domestic activities is an annualized $326.55 thousand. 9 9 Annualized present value of average costs is at a 7 percent discount rate over 10 years. Comment: A domestic seafood distributor stated that the proposed rule regulatory impact analysis underestimated the number of catfish processors in the U.S. A public policy organization stated that the data presented in the regulatory impact analysis were not properly attributed to a source, that no specific market failure or major health problem was identified, and that the theory behind the assertions was not articulated. The commenter further added that the regulatory impact analysis calculates a salmonellosis illness baseline without considering whether poultry processors used voluntary (fee-for-service) inspection services at the time, and that the numbers cannot be compared to the catfish industry. Response: The commenter provided no estimate of the number of affected catfish processors in the United States. In the proposed rule, FSIS used data from its research and site visits to project the number of affected domestic processors and distributors. The proposed rule regulatory impact analysis (RIA) data sources are in footnotes, tables, a list of references, and exhibits. In the final rule analysis, FSIS used the best available data from the Food and Drug Administration (FDA); National Oceanic and Atmospheric Administration (NOAA)/National Marine Fisheries Service (NMFS); import records of the U.S. Department of Homeland Security (DHS/CBP); and Dun and Bradstreet, and updated the presentation of summary data and its sources. As for the market failure, FSIS finds foodborne illness to be potentially consistent with an informational market failure; specifically, the market for food may be characterized by an asymmetry in which producers know more than consumers about the microbiologic status and chemical residue status of the foods they prepare and consume. While the proposed rule employed a risk assessment in its PRIA, the final rule employs a break-even analysis in its RIA. The break-even analysis was calculated using catfish data and did not incorporate findings from the risk assessment. Comment: A trade association stated that the proposed rule would deprive seafood processors of imported products that they need and would subject them to duplicative and costly regulation. Response: The 2014 Farm Bill amendments of the FMIA give FSIS jurisdiction over all Siluriformes fish and fish products, including Siluriformes fish and fish products imported from other countries. Through its planned outreach to affected entities, FSIS will address the continued importation of those fish species and will conduct records reviews and audits to verify that all countries that import those fish species to the U.S. maintain inspections systems and requirements that are equivalent to those of FSIS. See sections Q. Imported Products and R. Demonstrating Equivalence of Foreign Systems for additional discussion of how FSIS will evaluate the equivalence of these countries and conduct rulemaking to list these countries in the regulations. To prevent duplicative and costly regulation, the 2014 Farm Bill also instructed FSIS to execute a MOU with FDA to maximize the effectiveness of limited personnel and by ensuring that inspections of shipments and processing facilities are not duplicative, and that any information resulting from examination, testing, and inspections is considered in making risk-based determinations, including the establishment of inspection priorities. E. Trade Barriers and Agreements Comments: A comment stated that the proposed rule violated the World Trade Organization (WTO) National Treatment Principle, which states that imported and locally-produced goods should be treated equally once they enter the market. Another comment stated that the proposal violated the WTO agreement on Technical Barriers to Trade because it may be considered a disguised restriction on international trade. Some comments stated that the United States could be subjected to WTO-sanctioned tariffs if the rule is found by the WTO dispute settlement body to be noncompliant with its WTO obligations. A comment from a foreign government stated that it had been exporting catfish to the U.S. for many years under a food and feed safety agreement protocol with FDA, and that it hoped that the protocol would continue. Response: As with all other products FSIS regulates under the FMIA, this final rule would ensure that equivalent regulatory standards are applied to imported and domestic fish of the order Siluriformes. Therefore, this rule is not a violation of WTO National Treatment Principles. Imported products must be produced under an inspection system equivalent to the domestic system. F. Equivalency and Implementation Comment: Many domestic catfish farmers and processors and private citizens endorsed the concept of an exporting country's food safety system being held to equivalent standards that are applied to domestic production. A trade association strongly opposed phasing in the requirements because the phase-in jeopardizes the health and safety of consumers and is unnecessary because there has been ample time to comply. An aquaculture industry advocacy association stated that no catfish imports should enter the United States until the foreign system overseeing them is determined to be equivalent. The same association and a member of academia stated that requirements for domestic and foreign entities should have the same effective date. A foreign agricultural ministry requested that FSIS commit to a timeframe for equivalence determinations. Some commenters recommended possible timeframes for implementation. Response: The Agency has given the implementation of this final rule careful consideration and has outlined the Agency's implementation strategy in Section XII. Under this implementation plan, FSIS will begin implementing inspection of domestic Siluriformes producers and inspection of imported Siluriformes product at the same time, 90 days after the publication of this final rule. Siluriformes fish and fish products exported to the U.S. will be subject to species and residue testing. Also, at the start of implementation, 90 days after the publication of this final rule, foreign countries will have to submit written documentation identifying a list of establishments (with the establishment name and number) that currently export and will continue to export Siluriformes fish and Siluriformes fish products to the U.S., and demonstrating that they have laws or other legal measures in place that provide authority to regulate the growing and processing of fish for human food and to assure compliance with FDA's regulatory requirements. In addition, during the 18-month transitional period, foreign countries seeking to continue importing into the United States Siluriformes and products derived from these fish after the expiration of the transitional period are encouraged to start submitting their documentation demonstrating the equivalency of their Siluriformes fish and fish products inspection systems. In any event, such documentation must be submitted by the end of the transitional period. G. Facilities Requirements and Schedule of Operations Comment: A domestic seafood processor stated that the proposed requirement (9 CFR 533.1) for separation of inspected and non-inspected facilities would make it impossible for them to operate because of a lack of space, resulting in huge hardship. Response: Consistent with meat regulations in 9 CFR 305.2(a), FSIS generally considers a separation in time or space between inspected and non-inspected facilities to be sufficient, under certain conditions, to meet the requirement for separation of facilities. Therefore, common areas for inspected and uninspected operations may be used if the inspected product is acceptably maintained and protected to prevent product adulteration. Comment: A trade association suggested that the proposed phrase “docks and receiving room” (9 CFR 533.4(f)) be replaced with “existing plant receiving area” because it would be cost prohibitive to retrofit existing fish processing plant designs to meet the meat and poultry plant models. Response: Consistent with the meat regulations in 9 CFR 307.2, 9 CFR 533.4 requires the official Siluriformes establishment to provide docks and receiving rooms, designated by the operator of the official establishment, in consultation with the FSIS frontline supervisor, for the receipt and inspection of Siluriformes, Siluriformes products, and other products. These spaces are necessary to facilitate unloading and staging of products and to minimize the potential for cross-contamination that may occur through these activities. FSIS does not believe there is a meaningful distinction between “docks and receiving rooms” and “plant receiving area” and is not modifying the regulatory language in this final rule. The Agency does not anticipate that catfish plant designs will need to be significantly modified to comply with the regulations that contain this language. Comment: A trade association and a domestic processor asserted that the consistent work schedules and two weeks advance notice for schedule changes requirements, as proposed, will pose undue hardship on the catfish industry. The comments explained that operational hours necessarily fluctuate according to seasonal peaks, availability of fish, size of fish harvested, and other factors. Response: As proposed, the final regulations for a fish establishment's schedule of operations (9 CFR 533.5) cross-reference the meat regulations (9 CFR 307.4) that define a shift and the basic workweek and require each official establishment to submit a work schedule to their District Manager for approval. In addition, each official establishment will be required to maintain a consistent work schedule. Deviations from the work schedule must be submitted to the District Manager at least two weeks in advance. Establishments may also request overtime inspection, if needed; however, seasonal demands can only be met as resources allow. Consistent work schedules and prior notification for schedule changes are necessary to ensure that the Agency can maintain an inspector presence during establishment operations. However, the Agency does not want to pose undue hardships on establishments, and District Managers will take into consideration any work schedule change request. H. Definitions 1. “Adulterated” Comment: A domestic processor specifically requested that FSIS delete the phrase “ . . . an animal which has died otherwise than by slaughter,” paragraph (5) under the proposed “adulterated” definition (9 CFR 531.1). In addition, a trade association suggested FSIS use the definition of “adulterated” to mean any food safety hazard as defined in 21 CFR part 123. Response: As discussed in the proposed rule (76 FR 10441), the FMIA defines as adulterated a food product that is, in whole or in part, the product of an animal that has died otherwise than by slaughter (21 U.S.C.601(m)(5)), and the proposed “adulterated” definition in 9 CFR 531.1 is the same as the definition in the meat regulations (9 CFR 301.2). FSIS continues to view fish that died under circumstances other than the controlled circumstances of commercial fish harvesting and processing as adulterated under this provision of the FMIA and unacceptable for food. In cases where dead, dying, diseased, or otherwise unfit fish are in commerce, it may be necessary for the Agency to apply the detention, seizure, and condemnation provisions of the Act (21 U.S.C. 672, 673). 2. “Slaughter” and “Slaughterhouse” Comments: Several comments suggested various definitions of the term “slaughter.” A consumer advocacy group urged FSIS to provide a clear definition of slaughter that listed various acceptable methods of slaughter. A domestic processor suggested that “slaughter” be defined as “when the head is removed for processing.” A trade association stated that the catfish industry recognizes that slaughter, under controlled conditions, occurs at the de-header machine within the processing facility. An organization of regulatory officials recommended that FSIS define “slaughterhouse” to include locations where catfish may have died under conditions other than the controlled circumstances of commercial processing. This comment further added that a definition for “slaughterhouse” should also include locations where “wild-caught” catfish are processed. Response: After considering the comments, FSIS has concluded that the definition of “slaughter” as intentional killing under controlled conditions (9 CFR 531.1) is applicable to various slaughter methods, and it is not necessary to list all of the various methods in the regulations. In addition, the Agency does not see value in defining the term “slaughterhouse,” as the definition includes the phrase “under controlled conditions.” FSIS would consider fish that died under circumstances other than the controlled circumstances of commercial fish harvesting and processing to be adulterated under the FMIA and unacceptable for food, e.g., a fish that fell onto the pavement in the delivery area of a processing plant and lay there until it died would not be acceptable for human food. 3. “Farm-Raised” and “Wild-Caught” Comment: A trade association suggested that the proposed definition for “farm-raised” (9 CFR 531.1) be amended to require the control of enclosed bodies of water to prevent contamination. A domestic processor asked that the proposed definition be amended to include “raised in an enclosed environment of a clean, private, controlled water source.” A comment from a foreign government described the proposed definition for “farm-raised” as unreasonable because it does not consider the diversity of raising methods ( e.g., breeding in pools and floating cages) and is inconsistent with “the actual growth situation of catfish” in their country. The foreign country stated that the floating cage method is the general method used in their country, as well as other foreign countries. A member of academia stated that “wild-caught” catfish should be subjected to the same provisions of the rule as “farm-raised” catfish, including the testing requirements of the fish and water. A consumer advocacy group urged FSIS to require catfish establishments to segregate “wild-caught” fish from “farm-raised” fish during slaughter and processing. In addition, an aquaculture scientist stated that freshwater aquaculture needs an inspection and food safety system that differs from marine “wild-caught” seafood because hazards, their sources, and interventions differ significantly. Response: Proposed 9 CFR part 534 outlines the pre-harvest standards that FSIS will require to ensure that the environmental conditions and source waters in which the fish are grown will not render the fish unfit for food. These regulations require that fish harvested for human food, whether wild-caught or farm-raised, must not have lived under conditions that would render them unsound, unwholesome, unhealthful, or otherwise unfit for human food (9 CFR 534.1) so the fish would not be “adulterated” as the term is defined in 21 U.S.C. 601(m)(3) in the FMIA. The definition of “farm-raised” in 9 CFR 531.1 of the regulations is intended to cover a variety of fish-raising methods, including methods that involve raising the fish in pools and floating cages. Although the domestic fish growing process primarily utilizes fish-raising ponds, FSIS recognizes that wild-caught fish may be commercially processed. 9 CFR 534.2 states that farmers of fish should monitor the water in which the fish are raised for the presence of suspended solids, organic matter, nutrients, heavy metals, pesticides, fertilizers, and chemicals that may contaminate fish. FSIS will inspect wild-caught and farm-raised fish processed in official establishments and test them for metals, dyes, pesticides, and animal drug residues. The Agency does not see the need for requiring the segregation of “farm-raised” and “wild- caught” fish as they are processed in an official establishment. Comment: A consumer advocacy group requested that the manner by which the animal was raised, “farm-raised” or “wild-caught,” be required on the label. A similar comment requested that “wild-caught” fish be labeled as such to distinguish them from “farm-raised” fish. Response: FSIS is authorized under the FMIA to regulate the marking, labeling, and packaging of all Siluriformes products in commerce (21 U.S.C. 607). However, there is no statutory obligation to label fish with the raising claims “farm-raised,” or “wild-caught.” Establishments may choose to voluntarily label their finished product with such raising claims, if the claims are not false or misleading. Such claims for fish would not require FSIS approval as required by 9 CFR 412.1(c)(3) and 541.7(g). As discussed below, the final rule (9 CFR 541.7(b)) requires that country of origin statements on the label of any covered commodity (fish, including fillets, steaks, nuggets, and any other flesh) sold by a retailer must comply with the AMS regulations (7 CFR 60.200 and 60.300). For these products, the AMS regulations require method of production information (wild or farm-raised). I. Labeling 1. Mark of Inspection Comment: Several domestic processors, a consumer advocacy group, and an organization of regulatory officials recommended that the Federal mark of inspection be similar to the current brand for meat, poultry, and egg products. Another comment requested that the official inspection legend for catfish be unique in design and applied only to all finished packaging and in-process transfer containers. One comment favored assigning a number to each catfish establishment. Several comments noted that it may be impractical to stamp all carcasses of whole, gutted fish due to the size of the product and suggested alternative measures be considered, such as branding shipping containers, affixing inspection tags to lots, or marking invoices that accompany any shipments. Response: Because all fish of the order Siluriformes are amenable species under the FMIA, FSIS will require the same inspection legend for those products as it does meat products (9 CFR 312.2, reproduced in 9 CFR 541.2, respectively). This inspection legend includes the number of the establishment. FSIS recognizes that it may be impractical to physically apply the inspection legend to whole, gutted, fish carcasses. Therefore, whole, gutted fish carcasses that have been inspected and passed at an official establishment, and that are intended for sale as whole, gutted fish may be stamped with the official inspection legend or properly packaged in an immediate container and then labeled with the official inspection legend, as well as with all other required labeling features (9 CFR 317.2). For all other Siluriformes fish products, the inspection legend will be required on the immediate container. 2. Species Identification and Prevention of False or Misleading Labeling Practices Comment: One comment stated that FSIS should choose a rapid, accurate, and inexpensive method for catfish species identification. Another comment stated that FSIS should choose a method that provides accuracy at the species level. One comment stated that catfish products should be identified according to the species of fish throughout processing regardless of the final packing step location. Response: FSIS will determine fish speciation by appropriately validated methods which are published in the Chemistry Laboratory Guidebook on the FSIS Web site at http://www.fsis.usda.gov/Science/Chemistry_Lab_Guidebook/index.asp . The methods chosen by FSIS are state-of-the-art and appropriate for their purpose in determining fish species identification. The fish labeling regulations (9 CFR 541.7, cross-referencing part 317, subpart A) require the name of the product on the label (9 CFR 317.2(c)(1)). Product leaving an official Federal establishment for distribution in commerce for further processing would have to be properly identified with all applicable mandatory labeling features, including a product name. It would typically bear a statement of limited use, e.g., “for further processing” to limit distribution to another official Federal establishment. Because the product is intended for further processing, and not for retail sale, some labeling features would not be required because they would meet an existing exemption, e.g., nutrition labeling (317.400 (a)(3)), safe handling instructions (9 CFR 317.2(l)(4), and net weight (317.2(h)(1). Under the FD&C Act (21 U.S.C. 321d (a)), the term “catfish” is considered to be a common or usual name (or part thereof) only for fish classified within the family Ictaluridae; and labeling or advertising only for fish classified within that family may include the term “catfish.” Species of Ictaluridae include, among others, Ictalurus punctatus, I. furcatus, and Pylodictis olivaris, which may be identified as “channel catfish,” “blue catfish,” and “flat-head catfish,” on the labeling, if it is not false or misleading (9 CFR 541.7, cross-referencing part 317, subpart A, 9 CFR 317.8). Through fish speciation sampling and testing, FSIS will routinely verify that product is accurately labeled and not misbranded at official establishments and at import reinspection facilities. 3. Standards of Identity Comment: A domestic processor requested that all catfish products (as examples, formed nuggets, patties, cakes, gumbo) should contain at least 51 percent or more catfish. Response: Product standards are intended to ensure that products sold under particular names have the characteristics expected by consumers. FSIS will, if necessary and appropriate, apply any of the existing meat regulatory standards in 9 CFR part 319- that may be applicable, e.g., “meat stew” (9 CFR 319.304) to fish products. A mixture of Ictaluridae and other Siluriformes could be labeled with an accurate and truthful descriptive name identifying the Ictaluridae (catfish) and other species of the Siluriformes, e.g., “Catfish and Basa.” As stated in the preamble of the proposed rule, there are few further-processed fish products produced domestically (76 FR 10446), and FSIS is not aware of any fish standard-of-identity issues that require rulemaking. However, as provided in 9 CFR part 392, any person can petition the Agency to issue a regulation for a standard of identity. 4. Percent Approved Substances Comment: A trade association asked that the percentage of sodium tripolyphosphate, where allowed in catfish products (generally 0.5 percent by weight of the finished product), be explicitly addressed in the regulations to ensure that there is a uniform standard for domestic and foreign products. Response: 9 CFR 544 states that no fish product may bear or contain any food ingredient that would render it adulterated or misbranded or that is not approved in 9 CFR part 424 of subchapter E. 9 CFR 424.21 lists food ingredients that are approved for use in the preparation of meat products if they are used for the purposes indicated, within the limit of the amounts stated, and under other conditions specified. FSIS will apply the purpose and amount of any food ingredients to fish products, if appropriate, and in consultation with FDA. The purpose and amount of sodium tripolyphosphate listed in the table for meat food products that would be applicable to fish products is 0.5 percent in the meat food product to decrease the amount of cooked out juices. 5. Net Weight and Retained Water Comment: An aquaculture industry advocacy group stated that the net weight of Individually Quick Frozen (IQF) fish is not determined on a “thawed” basis, as suggested in proposed 9 CFR 541.7(b)(1). The commenter stated that while it is correct that the deglazed net weight must be 100 percent of the stated net weight, the procedure to determine this weight, as found in the NIST Handbook 133, does not thaw the product but only requires the removal of the outer layer of ice, and that the product is maintained in a frozen state. Additionally, the commenter stated that the net weight for IQF seafood is determined on a frozen basis. A domestic seafood distributor requested additional clarification on the section related to product moisture content and labeling because the proposed language is unclear on how to measure and label products that have undergone any kind of further processing. A foreign country's chamber of commerce stated that it would be impractical and serve no legitimate end to require catfish processors to calculate how much retained water is included in the production process. Response: NIST Handbook 133 net weight test procedures for the ice-glazed catfish products state that the products are “deglazed” by placing the product under a gentle spray of cold water, and that the product should remain rigid (Section 2.6.2.2). FSIS will follow this procedure for determining net-weight compliance for ice-glazed fish. However, the NIST Handbook 133 test procedure for Encased-in-Ice Product Only (Section 2.6.1.2), which includes frozen catfish, including IQF catfish, is to thaw the product before weighing. As explained in the proposed rule, the Agency proposed requirements for the control of retained water in catfish (76 FR 10445). FSIS will not permit retained water—water remaining in raw product after it undergoes immersion chilling or a similar process— in the packaged product unless the official establishment is able to show, with data collected under a written protocol, that the retained water is an unavoidable consequence of the process used to meet applicable food safety requirements (9 CFR 441.10(a)). To determine the amount of water retained in the product retained from a chilling process, an establishment may use physical water pick-up tests, weighing the product before the chilling process, and again just prior to final packaging and labeling. This is necessary because the amount of water retained in the product in excess of naturally occurring moisture must be prominently declared on the label. 6. Safe Handling Instructions Comment: A comment suggested that, to avoid confusion, one of the statements required within the safe handling instructions (9 CFR 541.7, cross-referencing part 317, subpart A), “This product was prepared from inspected and passed meat and/or poultry,” be modified to include the word “catfish” along with “meat and/or poultry.” Response: FSIS agrees that a safe handling statement referencing “meat and/or poultry” may potentially confuse consumers. Therefore, in this final rule, FSIS has modified the proposed codified language (9 CFR 541.7(a)) to require that the safe handling instructions rationale statement read, “This product was prepared from inspected and passed fish,” and the labeling statements read, “Keep raw fish from other foods. Wash working surfaces (including cutting boards), utensils, and hands after touching raw fish.” 7. Country of Origin Labeling Comment: Several private citizens, trade groups, and domestic processors requested that FSIS require that the country in which the catfish was hatched and raised, as well as processed, appear on the finished product label. Response: All shipping containers and immediate containers, as defined in 9 CFR 301.2, containing meat, including fish, imported into the United States for human consumption, must bear the name of the country of origin (9 CFR 327.14, 327.15; 9 CFR 557.14, 557.15). The proposed labeling regulations (9 CFR 541.7, cross-referencing 9 CFR, part 317, subpart A) require that catfish and catfish products be labeled in accordance with the Agricultural Marketing Service (AMS) country of origin notification labeling regulations in 7 CFR, part 65, subpart A (9 CFR 317.8(b)(40)). The AMS regulations require that covered commodities (as defined in 7 CFR 60.105) sold by a retailer, whether individually, in a bulk bin, display case, carton, crate, barrel, cluster, or consumer package contain country of origin and method of production information (wild or farm-raised) (7 CFR 60.200 and 60.300). The proposed rule cross-referenced AMS' Country of Origin Labeling (COOL) requirements for meat commodities. In this final rule, the Agency is correcting the regulatory text, by adding a paragraph to 9 CFR 541.7, to cite 7 CFR part 60, subpart A, “Country of Origin Labeling for Fish and Shellfish.” Establishments are not required to label their fish products with country of origin labeling. However, if an establishment chooses to place a label on a Siluriformes fish or fish product covered commodity with a country of origin statement, it must comply with the AMS regulations. Labels with country of origin claims can be generically approved, i.e., the labels can be prior-approved by the Agency without submitting such labels to FSIS for sketch approval (9 CFR 412.2). Generic label approval requires that all mandatory label features be in conformance with FSIS regulations. J. Pre-Harvest and Transport Conditions Comment: FSIS received several comments requesting that the final rule include performance standards for pre-harvest environmental and water conditions and transportation. A trade association stated that an FSIS monitoring program for water quality is unnecessary, and that water quality should be tested on a periodic basis, perhaps annually. Another trade association requested that any performance standards that the Agency develops should be clearly spelled out with adequate explanation for regulated parties to fully understand the new requirements. Response: The general pre-harvest requirements in 9 CFR part 534, require that fish harvested for use as human food must have grown and have lived under conditions that will not render them unsound, unwholesome, unhealthful, or otherwise unfit for human food. 9 CFR 534.2 requires that farmers of catfish monitor the water in which the fish are raised for suspended solids, organic matter, nutrients, heavy metals, antimicrobials, pesticides, fertilizers, and industrial chemicals that may contaminate the fish. FSIS will collect samples of feed, fish, and pond water on a case-by-case basis, for cause, i.e, if FSIS finds residues or diseases in tissue at slaughter. Establishments will be required address the hazards associated with “wild-caught” fish as part of their HACCP plans (9 CFR 417.2), and FSIS will verify that they carry out this monitoring. In addition, 9 CFR 534.4 requires that vats or other containers transporting fish must be maintained in a sanitary condition, and that sufficient water and sufficient oxygen must be provided to the vats that hold the fish to ensure that the fish are delivered to the processing establishment not adulterated. Comment: Several commenters stated that the regulations must address the quality of water used in transport vehicles. One trade association stated that proposed 9 CFR 534.4 should be amended to include the phrase, “. . . sufficient unpolluted and uncontaminated water and sufficient oxygen or aeration must be provided to the vats. . . .” Response: FSIS agrees with the comments but finds that no changes are necessary in response to the comments. In point of fact, the proposed regulations provided for the transport conditions the comments seek. Thus, the final regulation requires that sufficient water and oxygen be provided, and that vats or other containers be maintained in a sanitary condition, which includes the water in the vats (9 CFR 534.4). In addition, the regulations require that fish harvested for use as human food have been grown and have lived under conditions that will not render them or the products made from them unsound, unwholesome, unhealthful, or otherwise unfit for human food (9 CFR 534.1). Comment: A trade association and several domestic processors stated that it is not uncommon for live fish to come in contact with dead, dying, or diseased catfish during transport. Response: FSIS recognizes that live fish may, on occasion, come in contact with dead, dying, or diseased fish during transport. However, incidental contact during transport with dead, dying, or diseased fish would not automatically render an otherwise healthy fish adulterated. Under 9 CFR 548.2, adopted as proposed in this final rule, the establishment is required to prevent unsound, unhealthful, unwholesome, or otherwise unfit ingredients from being used in the preparation of products. 9 CFR 534.4 states that any fish that are dead, dying, diseased, or contaminated with substances that may adulterate catfish products are subject to condemnation at the official fish processing establishment. In cases where dead, dying, diseased, or otherwise unfit fish have entered commerce, it may be necessary for the Agency to apply the detention, seizure, and condemnation provisions of the Act (21 U.S.C. 672, 673). K. Pathogen Reduction and Tolerances for Animal Drugs Comment: FSIS received several comments requesting that the final rule include performance standards for pathogen reduction. Response: In the preamble of the proposed rule (76 FR 10444), FSIS stated that it planned to implement a pathogen reduction program for catfish that would be similar to that for other classes of raw product subject to the FMIA. After completing a study to determine the national baseline prevalence and levels of Salmonella on raw catfish, FSIS will conduct regular testing in processing establishments for the purpose of measuring industry performance against the baseline. If, after observing the industry's performance, the Agency determines the need for performance standards, it will publish the planned standards in the Federal Register , for public comment. Comment: Several comments suggested that the Agency stipulate “zero tolerance” for malachite green, crystal violet, enrofloxacin, ciprofloxacin, and other antimicrobials prohibited for use in the U.S. One comment requested that FSIS add regulatory requirements for appropriate disposition of catfish and lots of catfish found positive for these substances. Another comment asked that FSIS specify that only antibiotics approved for use in U.S farm-raised catfish be permitted for use in all catfish products sold in the United States, foreign or domestic. Response: The Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) have statutory authority for establishing antibiotic and other animal drug tolerances for meat, including fish. FSIS works with the EPA and the FDA to control drug, pesticide, and contaminant residues including antibiotics in meat products, including fish, by testing animal tissues to verify that tolerance levels are not violated. Fish or fish products and lots of fish containing violative residues of the drugs or other chemicals including those the commenters listed would be considered adulterated and subject to condemnation (9 CFR 539.2). L. Limits for Retail Quantities Comment: A domestic processor stated that a retail purchase is generally less than 30 pounds, and non-household consumers would purchase 60 pounds or more. An organization of regulatory officials remarked that the retail purchase limits stated in the proposal seemed reasonable, although difficult to verify. Response: FSIS is providing an exemption for retail stores and restaurants (9 CFR 532.3, paralleling 9 CFR 303.1(d) and (e)), using the poultry exemption regulations set out in 9 CFR 381.10 as a model. The final regulations provide a limit of 75 lbs. (single-sale) for an individual household purchase of fish to be considered a retail purchase; the corresponding limit for a non-household consumer would be 150 lb. Historically, these limits have been accepted as realistic, and, therefore, FSIS is not changing the limits in this final rule. M. Hard Copy Information Comment: A domestic food processor requested that FSIS simplify and minimize the collection and transfer of hard copy information. Response: FSIS is taking steps to minimize the use of hard copy. Inspection assignments in the fish inspection program will be incorporated into FSIS's computerized PHIS, as appropriate. Establishments have access to PHIS. The Application for Federal Inspection (FSIS Form 5200-2) and the Application for Label Approval and Instructions (FSIS Form 7234.1) are available in fillable Portable Document Format (PDF) on the FSIS Web site. The electronic Label Submission and Approval System (LSAS) is also available to fish establishments that do not or cannot have their labels generically approved. FSIS will provide for the electronic submission of information that it collects from entities that will come under its fish inspection regulations, where applicable. The Agency will continue to work to enhance its capacity for the electronic collection of information. N. Other Comments 1. Exemptions and Periodic Auditing Comment: A small domestic catfish processor requested that establishments that process less than 10,000 lb. of catfish products per week be exempted from the day-to-day FSIS mandatory inspection requirements. Additionally, the comment deemed a periodic audit system more appropriate for small scale operations than a mandatory inspection system. A similar comment suggested that the size of the catfish farm be taken into consideration when determining which farms are to be inspected. Response: The FMIA does not provide an exemption for fish processors that produce less than a specified amount of product. In addition, the exemptions for custom and farm slaughter and processing or other exemptions do not apply to fish (21 U.S.C. 623). The FMIA provides for the examination and inspection of conditions under which fish are raised. This requirement applies to all farms that supply fish to Federal establishments, regardless of the size of the farm. However, as discussed in Section XII, “FSIS Implementation,” through its 18-month transitional period, the Agency is providing establishments ample time to prepare and comply with the final regulations. In addition, during the 18-month transitional period, the Agency will exercise broad enforcement discretion, focusing particularly on preventing adulterated or misbranded Siluriformes fish and fish products from entering commerce. After the 18-month transitional period, FSIS will fully enforce all of the final regulations. 2. Use of Program Seals Comment: Some domestic processors and a trade association claimed that requiring a program employee to affix a seal to any means of conveyance will cause processors undue hardship, especially if program employees are unavailable during shipping times. Commenters contend that it is unnecessary and impractical to require the sealing of trucks, since the boxes of product inside the truck are inspected and sealed and are delivered to multiple locations. Response: A means of conveyance ( e.g., a truck) transporting inspected and passed fish products and bearing the official inspection legend (9 CFR 541.2; 9 CFR 325.5) is not required to be sealed by FSIS. The requirement for sealing railroad cars, motortrucks, or other means of conveyance applies when inspected and passed fish products are being transported from one official establishment to another, and the products are “unmarked”, i.e., they do not contain the official mark of inspection. Shipping inspected and passed, and properly marked, product does not require FSIS inspection and typically occurs outside the hours of inspection. FSIS did not change these provisions because establishments have flexibility in timing the application of seals to shipments. O. Cooperation With States Comment: An organization of regulatory officials requested that FSIS develop cooperative agreements with States for the inspection of catfish and catfish products. Response: Under 9 CFR 560.1, FSIS may cooperate with any State in developing and administering a fish inspection program that has requirements that are “at least equal to” the requirements of the FSIS inspection program. When resources allow, FSIS will enter into new State-Federal Cooperative Agreements under which the Agency will cooperate with, and provide assistance to, States carrying out inspection programs for fish and fish products that are to be sold intra-State. In addition, selected fish establishments in States that have and continue to maintain an “at least equal to” State meat inspection program will be eligible to ship their fish products across State lines and export them to foreign countries. In this final rule, FSIS is amending 9 CFR part 560 to include a paragraph specifically referencing 9 CFR 321.3, for the Cooperation of States for the Interstate Shipment of Carcasses, Parts of Carcasses, Meat, and Meat Food Products. P. Outreach and Training Comment: A trade association representing the storage industry asked that FSIS initiate substantial industry outreach to ensure regulated parties fully understand any new requirements and the phased-in implementation. Response: FSIS intends to develop necessary outreach materials and hold sessions to inform and educate fish establishment owners and operators of the regulatory requirements contained in the final rule. The timing of the 18-month transitional period is based in part on the need to ensure that domestic as well as foreign regulated parties understand FSIS's requirements. The implementation strategy is discussed in Section XII, and implementation information will also be posted on the FSIS Web site. XII. FSIS Implementation FSIS proposed a four-phase approach to implementing the catfish inspection rule, but did not provide timeframes for implementation (76 FR 10452). The final rule provides an effective date, 90 days after its publication, and an 18-month transitional period until the regulations are fully enforced. FSIS has given careful consideration in determining the nature of the inspection coverage that it will provide during the 18-month transitional period and once the rule is fully effective. In the proposed rule, FSIS used the term “continuous inspection,” but did not define what this would mean. The Egg Products Inspection Act uses the term “continuous inspection” (21 U.S.C. 1034(a)), and FSIS has interpreted it to mean that the Agency must have an inspector at an egg products plant whenever the plant is processing eggs. FSIS does not believe that Congress intended FSIS to provide this level of inspection coverage in establishments that slaughter and slaughter and process fish. Congress provided for inspection of fish in Section 606 of the FMIA (21 U.S.C. 606(b)). FSIS's longstanding and well-known interpretation of Section 606 is that it only requires inspection once per shift. If Congress had intended something [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2015-29793. Public record. Not legal advice.