Economic Impact of BSE
The USDA’s Food Safety and Inspection Service (FSIS) issued a notice announcing its preliminary regulatory impact analysis of three interim final rules and a notice issued by the agency in the January 12, 2004, Federal Register. The rules include:
• Designating certain high-risk tissues as specified risk materials (SRMs) and prohibiting the use of such materials for human food;
• Requiring the condemnation of non-ambulatory disabled cattle presented for slaughter and use in human food applications;
• Not awarding the mark of inspection on cattle tested for BSE under the Animal and Plant Health Inspection Service surveillance program until the test results are received and reported to be negative for BSE;
• Ensuring that advanced meat recovery (AMR) systems do not process SRMs and that boneless meat does not contain central nervous system (CNS)-type tissues or excess levels of bone solids and bone marrow;
• Prohibiting the use of certain stunning methods.
According to the analysis, the total annual cost of the actions related to the SRM and AMR interim final rules is estimated at $110.3 to $149.1 million. The total cost of the SRM interim final rule is estimated at $99.9 to $136.6 million, with the primary impact of the rule being the exclusion of SRMs from use in the human food supply ($35.6 to $36.7 million); the prohibition on non-ambulatory disabled cattle ($35.6 to $71.3 million); and modification of hazard analysis and critical control point (HACCP) plan/procedures, sanitation standard operating procedures, or other pre-requisite programs and record keeping requirements ($27.6 million).
The annual total cost of the AMR interim final rule is estimated at $10.7 to $12.5 million, with the primary impacts being restrictions on incorporating certain non-meat components in AMR products ($4.4 to $5.6 million); testing AMR products for iron, protein, and CNS-type tissues ($4.7 to $6.2 million); and revisions to HACCP and other plans, and bookkeeping requirements ($1 to $1.3 million). The annual cost of additional inspection, testing, and surveillance by FSIS is estimated at $3 million.
The analysis includes the impact these regulations will have on edible rendering, and “requests information on the types of changes in rendering practices that could be expected as a result of the SRM interim final rule.”
The complete economic analysis is available at www.fsis.usda.gov/OPPDE/rdad/FRPubs/03-025N/BSE_Analysis.pdf.
Animal Feed Safety System
Prior to the discovery of the U.S. BSE case, the FDA held a public meeting September 23-24, 2003, to discuss the potential development of a comprehensive, risk-based Animal Feed Safety System (AFSS). The AFSS is intended to describe how animal feeds (individual ingredients and mixed feeds) should be manufactured and distributed to minimize risks to animals consuming the feed and humans consuming food products from animals.
This spring, FDA placed in its docket numerous work products of the meeting, along with documents drafted by FDA following the meeting to show the agency’s tentative thoughts on AFSS. These include a transcript of the meeting, summaries of breakout discussion groups, presentations of invited speakers, and a summary of the meeting. Also included are draft definitions for the terms “comprehensive” and “risk-based,” and a listing of the elements FDA believes will be essential to an AFSS.
FDA is welcoming comments on the information at any time. For links to the AFSS public meeting information, FDA’s docket’s page, and information on how to submit comments, log onto www.fda.gov/cvm/index/updates/afssup.htm.
Registration Deadline Extended, Now Passed
FDA announced in an April 20, 2004, Federal Register notice that all parties required to register with the agency, including those that are currently registered, had until May 24, 2004, to file the new registration form that FDA has developed. On June 25, 2003, FSIS announced that it had developed the new registration form and that all businesses required to register with FSIS were to submit the form by March 22, 2004. FSIS extended that deadline because the new registration form was not available at the time FSIS projected that it would be.
The businesses required to register include those that engage in commerce as meat or poultry product brokers; renderers; animal food manufacturers and wholesalers of any carcasses or parts, or products of the carcasses of livestock or poultry; public warehousemen storing any such articles in or for commerce; and persons buying, selling, transporting, or importing any dead, dying, disabled or diseased livestock or poultry, or parts of the carcasses of livestock or poultry that died otherwise than by slaughter. Official establishments are exempt. The notice provides clarification regarding whether retailers are required to register and the differences between public and private warehouses.
The new registration form is available on the Internet at www.fsis.usda.gov/fsisforms.
Newsline - June 2004 Render