AMI’s Top Ten Goals and Objectives Food Safety Goal: Improve the safety of raw meat and poultry products and the safety of RTE, processed meat and poultry products through funding solutions-based research, sponsoring forums for industry to share best practices, and affecting FSIS domestic and international regulatory policies concerning those products. Objective: Continue to solicit, prioritize and fund research proposals aimed at providing solutions to the challenges of controlling and eliminating Listeria monocytogenes in RTE meat and poultry products, as well as E. coli O157:H7 in cattle and beef products and Salmonella in raw poultry, pork, beef and RTE products. Specifically, work to influence regulatory policies regarding E. coli O157:H7 so that such policies, domestically and internationally, are fact-based, practical, and meaningful. Seek new legislative and regulatory strategies to target additional government funding toward industry food safety research priorities. Oversee, finalize and disseminate research results to multiple audiences, including industry, government, and media. Provide educational op portunities to develop, share, and disseminate industry best practices for pathogen control. AMI Foundation Food Safety Initiative (Separate Binder) E. coli O157:H7 Regulatory Policy INFORMATIONAL MEMORANDUM ISSUE: THE EXPANSION OF E. COLI O157:H7 AS AN ADULTERANT ON BEEF IMPORTANCE: E. coli O157:H7 has been a concern in the meat industry since the 1993 outbreak in the Pacific Northwest and that caused the Food Safety and Inspection Service (FSIS) to declare the pathogen to be an adulterant in raw ground beef in 1994. No sampling program exists that will assure that the pathogen is not in the product. The ramifications of positive test results are significant in terms of regulatory action, plant operations, trade, crisis management, and media reaction. BACKGROUND: On January 19, 1999, FSIS expanded the existing policy regarding raw beef products such that beef products that have been injected or mechanically tenderized are considered adulterated if E. coli O157:H7 is found and the product is not processed into a RTE item. In addition, intact cuts that are to be processed into non-intact cuts (e.g., beef trim) before distribution are treated as non-intact cuts and are considered adulterated if E. coli O157:H7 is found. A 2002 FSIS notice identified that at any level whatsoever, E. coli O157:H7 is a hazard reasonably likely to occur. A Federal Register publication by FSIS in May 2005 made clear that “clean-up to clean-up” is no longer an adequate basis for lot definition if testing of the raw materials is not conducted in a manner that supports a distinction between raw materials used on separate days. FSIS Notices published in 2007 continue to focus sampling and testing on all raw materials for non-intact product, as well as at slaughter establishments that supplied such raw materials to processing establishments where positive test results are found. Because of an increase in the number of positive results and outbreaks in 2007, FSIS undertook a series of actions in an attempt to reduce the likelihood that raw, non-intact products will be adulterated with E. coli O157:H7. FSIS increased the number of verification samples taken throughout the supply chain from slaughter to the production of raw ground beef and other raw non- intact products, such as needle-tenderized and enhanced products. E. coli O157:H7 remains a focus in the Office of International Affairs (OIA) as well. Because of apparent lapses in operational and testing controls for E. coli O157:H7 at a single Canadian supplier, FSIS and OIA required all non- U.S. suppliers that want to export raw beef to the U.S. to re-evaluate and resubmit their E. coli O157:H7 control programs for approval (for equivalency); the key components of these revised programs were the sampling and testing frequencies, and the definition of lot size based on the verification testing program. FSIS remains committed to sampling and testing of imported products. Despite repeated requests from industry for labeling of imported trimmings that are destined for cook operations (and thus outside of the focus on the control of E. coli O157:H7 destined for raw, non- intact products), FSIS has decided not to allow any labeling of imported raw beef that would separate product destined for cooking from that destined for use in raw, non-intact products. 24 Informational Memorandum The Expansion of E. coli O157:H7 O157:H7 as an Adulterant On Beef Page 2 of 3 STATUS: On April 9-10, 2008, the agency conducted a public meeting regarding E. coli O157:H7 during which some agency officials presented new and troubling perspectives. In the meeting agency officials expressed concern about the number of outbreaks and recalls in 2007. Although a number of topics were discussed, two significant topics attracted most of the attention. First, FSIS officials stated that the agency is evaluating whether to identify six serotypes of non- O157:H7 shiga toxin producing E. coli as adulterants in raw beef products. According to FSIS six serogroups [O26, O111, O103, O121, O145, O45] are responsible for causing more than 80% of non- O157:H7 shiga toxin producing E. coli related illnesses. Regulatory action at this point is impractical because there is not a validated method for detection in agency labs and there are not commercially available test kits for differentiating these serotypes that could be used timely in a commercial setting by industry. FSIS intends, however, to begin a baseline study to look at the magnitude and prevalence of non-O157:H7 shiga toxin producing E. coli and will do so by using samples taken for E. coli O157:H7 under the current sampling program and analyzing them for non-O157:H7 shiga toxin producing E. coli. FSIS officials stated that the analysis would be “non-regulatory,” but advised that a "prudent establishment" would hold product subject to this testing. Second, FSIS is contemplating broadening the scope of when E. coli O157:H7 is an adulterant such that if the pathogen is present on any raw beef product or ready-to-eat product, the product would be considered to be adulterated. Agency officials indicated they would like to know what the industry is doing with regard to primals when establishment generated data suggests that the establishment may have lost control of the process (e.g. had positives for E. coli O157:H7 in trim or ground product). Although FSIS began collecting some data on prevalence of E. coli O157:H7 on primals in January of 2008, importantly, FSIS officials acknowledged that they have very limited data concerning the prevalence of E. coli O157:H7 on primals. Again, however, they do not intend to conduct a risk- assessment on intact beef products. Before the meeting, AMI sent a letter to Secretary of Agriculture Ed Schafer objecting to any change in agency policy along these lines. Other topics of interest discussed at the meeting include the following. • Agency officials expressed considerable concern about the number of establishments that reported through the survey using bench trimmings, or trim generated from sub-primals or mechanically tenderized primals in grinding operations. Thus, FSIS is considering ways to address the risk of incorporation of these components, with one possibility testing these components as part of the regulatory sampling program for E. coli O157:H7. • Sampling methods continue to be a point of discussion with the agency. Sampling of purge, and individual combo sampled at N=60 have been discussed by the agency. • Agency officials expressed concern that using head, cheek, or weasand meat in ground beef presents a higher risk of contamination with E. coli O157:H7 because, according to the agency, often these inputs are not subject to interventions aimed at reducing the microbial load. 25 Informational Memorandum The Expansion of E. coli O157:H7 O157:H7 as an Adulterant On Beef Page 3 of 3 • FSIS also expressed concern that beef slaughter establishments "threaten" their customers such that the slaughter establishments will stop supplying product if customers test the product for E. coli O157:H7 after receipt. FSIS officials stated that they may "step in" to address this “problem.” • The agency expressed concern about the use of informative or disclaimer statements, such as "not for use in grinding or non-intact product," by beef slaughter establishments as a means of passing off to further processors or retailers product that is positive for E. coli O157. • The agency is considering rulemaking that would require products sampled for pathogens to be held by the establishment pending negative test results. AMI POSITION: AMI opposed the declaration of E. coli O157:H7 as an adulterant in fresh beef products. Intervention efforts for pathogen control and reduction should be focused upstream, particularly the reduction of E. coli O157:H7 on hides of incoming animals and on carcasses. AMI will work with other industry trade associations to develop technological advancements to eliminate E. coli O157:H7 from the food supply, to develop more scientifically based sampling and testing programs, and to extrapolate these findings into improved regulatory policies. Also, AMI will work with the agency to suggest methods to improve the communication of company test results (COA’s) throughout the sales channel, has proposed the concept of hold and control of FSIS tested products in order to reduce recalls, and continues to gather information, including test methodology on non-E. coli 0157:H7 STEC. The level of E. coli O157:H7 in raw beef generally is so low that current, low- level sampling and testing cannot ensure the absence of the organism. Therefore, process control is a key factor in the reduction of this pathogen versus unwarranted expansion of test methods. AMI CONTACT: MARK DOPP JIM HODGES SENIOR VICE PRESIDENT EXECUTIVE VICE PRESIDENT REGULATORY AFFAIRS AND GENERAL COUNSEL RANDY HUFFMAN SCOTT GOLTRY PRESIDENT VICE PRESIDENT AMI FOUNDATION FOOD SAFETY AND INSPECTION AND SERVICES JULY 2008 26 Congressional Appropriations INFORMATIONAL MEMORANDUM ISSUE: FY2009 FOOD SAFETY FUNDING REQUESTS IMPORTANCE: Government involvement in the food safety arena should be focused on science- based, risk-assessed, intervention, applied research and education initiatives that can improve the safety of the food supply as measured by public health outcomes. BACKGROUND: Each fiscal year Congress appropriates funds to federal agencies to carry out their functions, including funds that are directed for research programs. The House and Senate Appropriations Subcommittees on Agriculture have jurisdiction over the funding that is approved for research activities conducted by the U.S. Department of Agriculture. Since Fiscal Year 2000, AMI asked Congress to approve research funding to help augment private sector research directed at eradicating two food-borne pathogens: E. coli 0157:H7 and Listeria monocytogenes. In 2005 and with AMI’s urging, Congress added Salmonella as key pathogen to control. The funding is directed through two accounts, one with the Agriculture Research Service (ARS) and another at the Cooperative, State, Research, Extension and Education Service (CSREES). The CSREES funding is largely directed to an AMI supported project at Cornell University. AMI’s Jim Hodges and Randy Huffman serve advisory committees to evaluate and provide recommendations to these agencies on meat and poultry safety funding. Depending on budget and political developments, AMI has been successful in maintaining and increasing the funding levels in a number of years and in improving the designation for the direction of the funds. AMI also attempted unsuccessfully to have funding directly sent to the Foundation for meat and poultry safety research. Unrelated to food safety, but also important, Sen. Specter (R-PA) included a request on AMI’s behalf to increase research on hides and leather at USDA-ARS’ Eastern Regional Research Center in Wyndmoor, PA. The research is focused on providing the hides and leather industry with cost- effective and environmentally safe tanning processes which will enhance U.S. producers’ competitiveness in world markets. STATUS: In May 2007, AMI submitted two funding request for the ARS and CSREES account, requesting Congress to maintain and increase each account by $500,000. AMI pursued the larger increases this year because USDA’s National Research Initiative removed food safety research funding for red meat as it relates to key pathogens. Additionally, AMI pursued an additional $250,000 increase for Hide and Leather research to be conducted at USDA’s Eastern Regional Research Lab. 27 Informational Memorandum FY 2008 Food Safety Funding Requests Page 2 of 3 In July 2007, the full House of Representatives approved the Agriculture Appropriation’s bill for FY2008. Included in the bill is an increase of $134,339 for ARS monies and $990,000 for pathogen research at Cornell. The final bill included an increase of $124,620 for ARS and $990,000 for CSREES. The odd number reflects a 0.7 percent across the board reduction for all programs. These levels total pathogen/food safety research monies for ARS for FY2008 will be $2.863 million. TABLES Total USDA/ARS Funding for Food Safety Research 2000 $1,000,000 2001 $1,750,000 2002 $1,990,000 2003 $2,340,000 2004 $2,340,000 2005 $2,639,000 2006 $2,739,000 2007 $2,739,000 2008 $2,863,620 Cumulative Total $20,400,620 Total USDA/CSREES Funding for Food Safety Research 2001 $289,000 2002 $800,000 2003 $900,000 2004 $805,000 2005 $900,000 2006 $1,000,000 2007 $1,000,000 2008 $990,000 Cumulative Total $6,684,000 In March 2008, AMI prepared and submitted a request for continuation and a $500,000 increase for the ARS budget and to refine its language to directly address meat and poultry safety challenges. Also, in March, the House and Senate Agriculture appropriations committees began their budget hearing process. As the appropriations process moves forward, AMI will continue to push for continuation and an increase in this account. An emerging risk in food safety research funding is an effort by USDA to direct more monies to fruits and vegetable research and away from meat and poultry. Some of the reprogramming of funds would move funds that are part of long standing programs where the agency made multi-year investments. AMI is working with key congressional offices to see that meat and poultry safety research remains and potentially increases. 28
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