FOOD SECURITY UPDATE
The Alliance for Food Security was established by NFPA to address food security issues arising from the September 11 terrorist attacks on the US. The industry-wide Alliance has met each Friday since September 28 to discuss and share information on this critical issue. On September 28 there was an organizational meeting among the trade associations. On October 5 the guest speaker was Mr. Michael Moodie, President of the Chemical and Biological Arms Control Institute. Also present were representatives from FDA, EPA, CDC and FSIS. On October 12, FDA’s Janice Oliver and Bob Brackett shared with the Alliance a draft document titled “Guide to Food Safety and Security,” which explained the Operational Risk Management (ORM) process. Dr. (Col.) Larry Barrett, State of California and the Air Force, presented a summary of the information and has offered to provide a workshop to interested NFPA members to explain the objectives and “how to’s” for conducting the ORM process. A workshop will be held at NFPA on October 18 from 9-2 for a limited audience.
NFPA, in addition to other trade groups, met October 4 with USDA representatives to discuss USDA actions since September 11. It was stated that all information is being funneled through National Security and will be shared (if possible) at a later date. It was of interest to note that when the question was asked to identify the highest risk, the response of the commodity groups was a resounding “IMPORTS.” FDA has also been hosting meetings with various food industry groups. On October 12 Janice Oliver updated the Alliance on FDA activities. FDA is looking at the CDC Morbidity and Mortality Weekly Reports article (see below) with respect to foods. FDA has contracted with Battelle to conduct a threat assessment of foods and the likelihood for biological and chemical agents to survive. This will be shared with industry, however the report will not be complete until March 2002. FDA is also meeting with numerous parties to evaluate prevention, preparedness and emergency response with respect to domestic and imported foods. FDA believes we need to monitor more and is gathering information to determine what and how. This information will also be shared with industry.
Some information that may be of use to members is noted below.
CDC Biological and Chemical Terrorism Strategic Plan for Preparedness and Response: Recommendations of the CDC Strategic Planning Workgroup. Morbidity and Mortality Weekly Reports Vol 49, No RR04;1 (4/21/00) http://www.cdc.gov/mmwr/PDF/RR/RR4904.pdf
http://www.who.int/emc/pdfs/BIOWEAPONS_FULL_TEXT2.pdf
Chemical and Biological Arms Control Dispatch, Prepared by the Chemical and Biological Arms Control Institute http://www.cbaci.org/
“The Arena – Agricultural Biological Warfare: An Overview,” Chemical and Biological Arms Control Institute (June 2000) http://www.cbaci.org/
ORA’s Division of Emergency Operations and Office of Enforcement update (1997 RPM with updates through 3/20/2001) http://www.fda.gov/ora/compliance_ref/rpm_new2/
Revised Federal Response Plan (4/99) http://www.fema.gov/r-n-r/frp/frpfull.pdf
For further information, contact Rhona Applebaum at 202/639-5958 (mailto:[email protected]” style=”color: blue; text-decoration: underline; text-underline: single”>[email protected]).
REGULATORY OFFICIALS UPDATE
USDA
On October 2, following her Senate confirmation the previous week, Dr. Elsa A. Murano, was sworn in as Under Secretary for Food Safety by Agriculture Secretary Ann M. Veneman in a private ceremony. As the Under Secretary for Food Safety, Murano is USDA’s top food safety official and oversees the policies and programs of the Food Safety and Inspection Service. The USDA press release on this issue is available at: http://www.usda.gov/news/releases/2001/10/0191.htm Complete biographical sketches and photographs of subcabinet members are available at http://www.usda.gov
Dr. Murano’s September 26 confirmation by the unanimous consent of the Senate followed her confirmation hearing before the Senate Agriculture Committee. Murano was questioned during the brief and cordial hearing by Senator Tom Harkin (D-IA) about biosecurity and microbiological performance standards. Regarding performance standards, she indicated that USDA was looking directly to the scientific information that would be forthcoming from the National Academy of Sciences and the NACMCF. She discussed the need for science-based solutions to the application of microbial performance standards and indicated her faith in the expertise of the scientists conducting the reviews. NFPA officials noted that they look forward to working closely with Dr. Murano, and to continuing the cooperative efforts between the food industry and government to further ensure the safety of our nation’s food supply.
FSIS Administrator, Tom Billy has officially moved out of the Administrator’s office, relocating to the second floor of the Whitten Administration Building. This move is in preparation for his transition from FSIS Administrator to Special Advisor to the Secretary. In the new position, Billy will have more time to devote to his duties chairing Codex. An announcement on this move is expected within the next week. Maggie Glavin, currently the Associate Administrator, is expected to be named as Acting Administrator and appears to be a frontrunner for the permanent position.
Also of interest regarding USDA/FSIS personnel changes: The current FSIS District Manager for the Beltsville, MD District, Perfecto Santiago, has been selected to replace Pat Stofla, who recently retired, as Assistant Deputy Administrator for Program Development in the Office of Policy, Program Development and Evaluation. Dr. Santiago, a veterinarian, has served in various FSIS field operation positions during his career. The Agency has also appointed Dr. D.W. Chen as Director of Human Health Services in the Office of Public Health and Science. Dr. Chen, a physician with specialties in organ transplants, is replacing Dr. Ruth Etzell.
FDA
Department of Health and Human Services (HHS) Secretary Tommy Thompson has apparently made Lester Crawford, DVM., PhD, his choice for Commissioner of the Food and Drug Administration (FDA). Crawford has been Director of the Georgetown University Center for Food and Nutrition Policy, which recently change its affiliation to Virginia Tech. Crawford’s prior positions include FSIS Administrator, director of FDA’s Center for Veterinary Medicine and a stint as NFPA’s EVP for Scientific and Regulatory Affairs. According to Food Chemical News, Crawford’s nomination was to have been officially announced this past week; however, it has been postponed due to a focus on the war on terrorism.
For further information, contact Lloyd Hontz at 202/639-5924 ([email protected]).
GAO REPORT ON FOODBORNE DISEASE SURVEILLANCE
GAO has recently released its September 2001 report “Food Safety: CDC Is Working to Address Limitations in Several of Its Foodborne Disease Surveillance Systems” (http://www.gao.gov/cgi-bin/getrpt?gao-01-973). GAO was asked by Senator Tom Harkin (D-IA), Chairman of the Committee on Agriculture, Nutrition and Forestry, to describe CDC’s foodborne disease surveillance systems and identify their limitations, along with initiatives designed to address them. In addition to meeting with CDC, GAO obtained information from FDA, USDA, the Council of State and Territorial Epidemiologists and others and sent questionnaires to officials in the 50 state health departments, the District of Columbia and New York City (all of which were completed and returned). The report provides a very useful description of the many CDC surveillance programs for foodborne disease, with major focus on the Foodborne Disease Outbreak Surveillance System (which relies on reporting by state and local officials and is used to compile national outbreak data); FoodNet (which conducts active surveillance in nine selected sites); PulseNet (the national network that performs DNA fingerprinting of Salmonella, E. coli O157:H7, Listeria monocytogenes and Shigella); and the Surveillance Outbreak Detection Algorithm (which uses statistical analysis to compare reported incidence of serotypes of Salmonella and Shigella to a historical baseline to detect unusual increases that may signal an outbreak).
The two major criticisms of the surveillance systems were delayed reporting and incomplete data. Reasons for these included staff shortages at CDC, shortages of trained epidemiologists at state and local health departments, and differences in diseases tracked among the states. It was noted that CDC did not publish the summary of outbreak data for 1993-1997 until March 2000 and that CDC has yet to publish detailed results from its FoodNet case control studies about the proportion of foodborne disease caused by specific foods or food preparation and handling practices. CDC responded that it intended to release outbreak data annually, beginning with the 1998 data, and is currently compiling 2001 outbreak data for publication by the end of 2002. CDC also plans to publish by the end of 2001 a number of case control study results. CDC’s ability to disseminate surveillance data in a timely manner depends in part on the timeliness of state and local officials submissions. CDC is developing a National Electronic Disease Surveillance System intended to facilitate the exchange of data between local and state health departments, among states, and among states and CDC.
To improve local and state health officials’ ability to respond to a broad range of public health issues, including foodborne outbreaks, CDC provides funding to state and local health departments through its Emerging Infections Program and its Epidemiology and Laboratory Capacity Program. These programs are designed to address staffing and technology shortages. CDC consults with the Council of State and Territorial Epidemiologists to encourage more standardized reporting among the states. CDC has entered into cooperative agreements with the Council and with the Association of Public Health Laboratories to assess the states’ capability and capacity to address public health issues, including foodborne illnesses.
For further information, contact Jenny Scott at (202) 639-5985 ([email protected]).
NAS REVIEWS E. COLI O157 RISK ASSESSMENT
On Monday, September 24, the Committee on the Review of the Draft USDA E. coli O157:H7 Farm-to-Table Process Risk Assessment met at the offices of the Institute of Medicine of the National Academy of Sciences. The Committee met in closed session in the morning and late afternoon; the meeting was opened to the public from approximately 9:30 a.m. until 2:30 p.m.
The Committee consists of the following members:
Michael Doyle, Chair (University of Georgia)
Scott Ferson (Applied Biomathematics)
Dale Hancock (Washington State University)
Myron (Mike) Levine (University of Maryland)
Greg Paoli (Decisionalysis Risk Consultants, Inc.)
Barbara Peterson (Novigen Sciences)
John Sofos (Colorado State University)
Susan Sumner (Virginia Tech)
After introductions, Kaye Wachsmuth, USDA/FSIS, reviewed the USDA charge to the Committee. She indicated that the risk assessment will be made publicly available through a Federal Register notice and that FDA, CDC, NACMCF, and select individuals have reviewed the draft. [According to a National Advisory Committee on Microbiological Criteria for Foods member, no in-depth review was conducted. – js] It has also been presented at the Society for Risk Analysis annual meeting. This risk assessment will be used to evaluate available risk management strategies. The charge to the Committee is to look at the over-arching logical structure of the risk assessment, the validity and appropriateness of the input data, the reasonableness of the assumptions, and the model mathematics. The group was also to assess whether the risks have been appropriately characterized. The risk assessment model was reviewed by Wayne Schlosser and Eric Ebel, both of USDA/FSIS Office of Public Health and Science; no handouts were provided to observers. The study is supposed to last eight (8) months.
For further information, contact Jenny Scott at (202) 639-5985 ([email protected]).
NACMCF MEETING CANCELLED
The National Advisory Committee on Microbiological Criteria for Foods (NACMCF) was scheduled to meet the week of September 17; however because of the terrorist attacks the prior week, the meeting was cancelled. It would appear that a meeting of the full Committee will not be rescheduled until sometime in January (possibly the week of January 21). The Subcommittee on Meat and Poultry Performance Standards may meet in early December. In the meantime, the various working groups have been meeting via conference call to finish-up the deliberations on their draft reports.
For further information, contact Alice Johnson at (202) 639-5983 ([email protected]).
BSE IN SLOVAKIA
On Thursday, October 4, The Slovak Agriculture Ministry announced that tests by German laboratories confirmed the country’s first case of Bovine Spongiform Encephalopathy (BSE). Slovakia is the second eastern European state in which BSE has been confirmed. Two cases were discovered in the Czech Republic this past summer.
For further information, contact Lloyd Hontz at (202) 639-5924 ([email protected]).
FOODBORNE ILLNESS FROM PROVIDENCIA
The October 15 issue of the Journal of Infectious Diseases contains a report from Japan on an outbreak of foodborne illness in November of 1996 attributed to Providencia alcalifaciens. According to the abstract, no other recognized enteropathogens were detected in fecal samples, but P. alcalifaciens was detected in 7 of 18 samples. PFGE analysis indicated the isolates were clonal, suggesting they might be from a common source. The patients with gastroenteritis had elevated levels of antibody specific to the isolated strain. The isolates could invade Caco-2 cells and produced fluid accumulation in rabbit ileal loops. The abstract contains no details on the outbreak itself, nor identification of a food vehicle. The abstract claims that this is the first report of a large outbreak of foodborne infection attributed to the organism and provides definitive evidence that P. alcalifaciens is a causative agent of gastroenteritis.
The full citation for the article is as follows:
Murata, T, T. Iida, Y. Shiomi, K. Tagomori, Y. Akeda, I. Yanagihara, S. Mushiake, F. Ishiguro, and T. Honda. 2001. A large outbreak of foodborne infection attributed to Providencia alcalifaciens. J. Infect. Dis. 184: 1050-1055.
For further information, contact Jenny Scott at (202) 639-5985 ([email protected]).
SINGLE FOOD SAFETY AGENCY HEARING
On October 10 Chairman Richard Durbin (D-OH) and Ranking Member George Voinovich (R-OH) held a hearing before the Subcommittee on Oversight of Government Management, Restructuring and the District of Columbia, to discuss the structure of the US food safety system (“single food safety agency”). Those who testified before the committee presented a divided view on the concept of a single food agency. Durban and Voinovich called upon those testifying to provide the Agencies and the Committee with proposals to improve the overall food safety system. NFPA has already begun to work with members to quickly develop and communicate our suggested policy proposals to the Administration.
Testifying before the committee were Robert Robinson, GAO; Rep. Rosa DeLauro (D-CT); Elsa Murano, FSIS; Bernie Schwetz, FDA; Dan Glickman, former USDA Secretary; Michael Jacobson, CSPI; John Cady, NFPA; Peter Chalk, Rand Corp; Manly Molpus, GMA; Tim Hammonds; FMI. Brief summaries of the comments follow.
Robert Robinson, GAO
Robinson testified that the GAO has long called for a single food agency. He criticized the current system as inefficient and inflexible and used the example of an open-face sandwich and closed-face sandwich being inspected by different agencies. Robinson pointed out that in times of crisis precious time may be wasted as the Agencies try to decide who has jurisdiction over a recall or biological attack. Robinson, in responding to a question by Durbin, clarified that the GAO is recommending an independent agency. He pointed out that other countries have or are developing their own single food agency, including Canada, the UK and the EU. During this exchange Durbin pointed out the lack of political will to develop a single US food agency, as well as concerns in Congress and the Agencies over jurisdiction and division within the industry.
Rep. Rosa DeLauro (D-CT)
Rep. DeLauro spoke briefly regarding her single food agency bill, H.R. 1671, which is nearly identical to the bill introduced by Chairman Durbin, S. 1501, cosponsored by Clinton, Mikulski, and Torricelli.
Elsa Murano, FSIS
The new Under Secretary for Food Safety described USDA’s food safety infrastructure, noting the many places where there are cooperative efforts. Murano discussed how PulseNet, FoodNet and the USDA internal working committees are increasing vigilance in monitoring foodborne illnesses. She testified that USDA is working closely with HHS to develop emergency rapid response plans in the event of a food security scare. When asked about FSIS recall authority, Murano assured the Committee that USDA has adequate seizure and detention authority. She pointed out the real question is who has the responsibility for recalling products, intimating that industry plays a critical role in this process. Murano testified that science and risk analysis should be the basis of any change in the food safety system and that better cooperation and communication is needed. Dr. Murano concluded that she would continue to pursue enhancements in the safety of the food system by establishing a seamless, science-based process and by strengthening coordination with other agencies involved in the food safety system. In response to a question, she said that she is open to discussions of combining duties and resources. Dr. Murano’s prepared statement can be found on the FSIS website at www.fsis.usda.gov/oa/congress/test_murano101001.htm.
Bernie Schwetz, FDA
The Acting FDA Commissioner discussed how FDA has increased surveillance, education and research to ensure an adequate response level to possible food security threats. Schwetz told the Committee FDA needs more inspectors at the borders, more enforcement authority, and resources to support their current and any upcoming challenges. He testified that FDA is preparing for the possibility that food could be a medium for a biological attack on the US. In a discussion of whether FDA has the authority to withdraw products from the market in the event of an epidemiological scare related to food, the Acting Commissioner indicated that he did not believe FDA had the current authority to recall food from the market place. When asked directly by Voinovich if the Administration supports Sen. Durbin’s bill, the Commissioner testified that the bill addresses some problems but that the Administration has not taken a position on the bill. He also testified that the current system is working and improvements are being made.
Dan Glickman, former USDA Secretary
Glickman testified that he is in favor of a single food agency with increased civil money penalty and recall authority, more inspectors, and more resources. He testified that what is needed is central control of resources and a central decision-making structure. He pointed to StarLink as an example of a crisis that could have been better controlled by a single food agency.
Michael Jacobson, CSPI
Jacobson gave anticipated testimony spelling out the lack of resources for FDA and inspection authority. CSPI endorses the Durbin bill.
John Cady, NFPA
Cady stressed that the current system works well. He advocated for more resources for FDA to update its import tracking system (OASIS) but indicated that no new authorities were necessary. He testified we should take no actions that will lessen public confidence in our food safety system or compromise the effectiveness of current programs. Cady testified we must develop a unified science- and risk-based food safety policy, rather than creating a new bureaucracy. He also noted the existence of the Alliance for Food Security, through which industry associations are coordinating and communicating with federal agencies on food security issues, and expressed confidence in the work being done by both government agencies and industry to ensure that systems are in place to adequately address threats to our food supply. In response to a question posed by Durbin, Cady stated the current system must be supported with the proper budget and be based on risk analysis. He agreed that there are gaps in the system but pointed out the current system is based on science and the problems lie in the limitation on resources. Cady added that what is missing in the current debate is an examination of the millions of dollars industry spends on food safety. He pointed out the answers do not lie in increasing civil money penalties and politicizing food safety. In response to question posed by Voinovich, Cady testified that NFPA assists companies in times of food recalls and he has never had a problem with the Agencies in times of crisis. He committed that NFPA would work with the Committee and Agencies in providing a proposal for changes needed. He pointed out that those interested need to look at the details and not make the same mistake made when the Federal government merged agencies to form the EPA. Voinovich agreed.
Peter Chalk, Rand Corp
Chalk, a terrorism expert, testified that there is a great need to protect the US agriculture infrastructure. He mentioned the need to protect against animal diseases and security at large processing facilities and animal farms. He recommended the US place more emphasis on diagnostic training and veterinarian sciences. He endorsed the single food agency concept.
Manly Molpus, GMA
Molpus’s comments were similar to the comments made by NFPA. He quoted a Gallup poll that showed there is high confidence in the US food supply. GMA believes that both agencies should receive adequate resources and staffing; stress research and science; and better coordinate with each other; and that inspections of imported food should be improved.
Tim Hammonds, FMI
Hammonds testified that FMI endorses moving food safety responsibility to one of the currently existing agencies, and he indicated that this could be accomplished without disturbing the oversight authority of the current committees of jurisdiction in the House and Senate. He pointed out the Federal government does not often quickly respond to food safety scares and that the nation needs a unified reassuring voice in times of national crisis.
For further information, contact Kristin Pearson at (202) 639-5937 ([email protected]) or Kelly Johnston at (202) 639-5939 ([email protected]).
SUPREME BEEF APPEAL
On October 1, judges of the 5th Circuit Court of Appeals heard USDA’s arguments seeking to reverse a district court decision in Supreme v. USDA now that Supreme Beef Processors has filed for Chapter 7 bankruptcy. When questioned about Salmonella as an indicator microorganism, the U.S. attorney agreed that Salmonella is a proxy and that it is used as an indicator for E. coli O157:H7 (which is an adulterant in ground beef, whereas Salmonella is not). The judges hearing the appeal also questioned why USDA does not do quantitative testing and the role of USDA versus the industry in testing for the organism. Other witnesses included a representative from consumer organizations, as amicus, a representative from Supreme Beef and a representative from a meat trade group, also as amicus. Legal counsel for Supreme Beef filed additional statements this week questioning the U. S. attorney’s statement on the relationship between O157:H7 and Salmonella, as the statement appears to be in direct conflict with the Agency’s language in the preamble to the HACCP/Performance Standard regulation.
For further information, contact Alice Johnson at (202) 639-5983 ([email protected]).
2002 FDA SCIENCE FORUM
The 2002 FDA Science Forum will be held February 20 and 21, 2002, 8:00 a.m. – 4:30 p.m. at the Washington, DC Convention Center. The Forum will focus on how FDA’s many different scientific and regulatory disciplines support the public health programs of the agency. The first day will discuss the importance of research, policy development, and review in public policy decision-making. The second day will emphasize how the principles of public health surveillance, from both domestic and global perspective, can be applied to FDA’s science issues. An integral part of this year’s science forum will be interactive breakout sessions that discuss in depth the importance of research, review, policy and regulation in the development of FDA’s public health policies. The break out session topics will include bioengineered foods, botanicals, bioterrorism, antibiotic resistance, children’s health issues, tissue engineering, genomics, and bovine spongiform encephalopathy. The break out sessions on the first day will focus on the importance of sound research and review in responding to public health issues. The break out sessions on the second day will focus on impact of policy and regulation on public health programs. For additional details go to http://www.fda.gov/oc/meetings/2002sciforum.html.
For further information, contact Jenny Scott at (202) 639-5985 ([email protected]).
JUICE HACCP WORKSHOPS
The next two HACCP Courses for Juice Processors are scheduled as follows:
October 24-26, 2001 NFPA Conference Center 1350 I Street, NW Washington, DC 20005
November 14-16, 2001 Tampa Marriott Waterside Hotel 700 South Florida Avenue Tampa, FL 33602
FDA’s “Juice HACCP” regulation (21 CFR, Part 120) goes into effect January 22, 2002 for the largest juice processors. Any juice sold as such or used as an ingredient in beverages must be manufactured according to these new regulations. NFPA and its education provider, the Food Processors Institute (FPI), have developed this 2½-day course, which is designed to meet the educational requirements cited in the FDA regulation requiring HACCP for juice products (21 CFR, Part 120).
For further information, visit FPI’s website, www.fpi-food.org or contact Lisa Weddig at (202) 639-5944 ([email protected]) or Jennifer Epstein at (202) 637-4818 ([email protected]).