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Food Safety and Inspection
Service United States Department of Agriculture Washington, D.C. 20250-3700 |
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Food Safety and Inspection
Service United States Department of Agriculture Washington, D.C. 20250-3700 |
Communications to Congress
March 2001
During fiscal year (FY) 1999, FSIS continued to make noteworthy progress with its farm-to-table food safety strategy. This strategy is designed to better protect the public’s health by improving the safety of meat, poultry, and egg products at each stage in food production, processing, distribution, and marketing.
Transformation of the 90-year-old inspection system continued throughout FY 1999, whereby traditional command and control methods were transformed to a science-based system that targets and prevents contamination of meat and poultry products with harmful bacteria and other food safety hazards. The foundation for this transformation is the Pathogen Reduction and Hazard Analysis and Critical Control Point (HACCP) rule, issued by FSIS on July 25, 1996. The rule clarifies the roles of government and industry in food safety. Industry is accountable for producing safe food, while government is responsible for setting appropriate food safety standards, maintaining vigorous inspection to ensure those standards are met, and maintaining a strong enforcement program to deal with plants that do not meet regulatory standards.
The rule (1) requires that each plant develop and implement written standard operating procedures for sanitation to reduce the likelihood that harmful bacteria will contaminate the finished product; (2) requires regular microbial testing by slaughter establishments to verify the adequacy of their process controls for preventing and removing fecal contamination; (3) established pathogen reduction performance standards for Salmonella that slaughter plants and plants producing raw ground products had to meet; and (4) required that all meat and poultry plants develop and implement HACCP systems to prevent food safety problems, by addressing microbial, chemical, and physical hazards reasonably likely to occur.
The rule contains four separate phases, or implementation dates, the first three of which were met by the end of FY 1999:
January 25, 1999, marked the implementation of Phase II of the HACCP final rule. HACCP is a process control approach used to reduce and prevent contamination of meat and poultry products. Approximately 2,300 small meat and poultry plants (those with between 10 and 499 employees) were required to have HACCP systems in place. During Phase I, approximately 300 large plants came under HACCP by January 26, 1998. Approximately 3,400 federally inspected and 2,400 State-inspected very small plants were to implement HACCP during Phase III by January 25, 2000.
FSIS conducts training to ensure that inspection and compliance personnel are trained in time for various implementation dates, and to ensure that they are prepared to function successfully in the new HACCP work environment. FSIS made significant progress in training its workforce to carry out new regulatory tasks and procedures generated by the HACCP final rule. Over 92 percent of the inspection workforce was trained in HACCP as of the close of FY 1999. Specific HACCP training-oriented accomplishments during FY 1999 include:
FSIS recognized early on in the HACCP implementation process that both small and very small plants would benefit from guidance and assistance that the large plants implementing HACCP in 1998 did not require. In order to meet these needs, a number of outreach programs have been implemented. These programs were tailored to meet the specific needs of both small and very small plants. In 1999, approximately 2,300 federally inspected and nearly 200 State-inspected small plants implemented HACCP. In 2000, more than 3,400 federally inspected and 2,300 State-inspected plants were to implement HACCP.
FSIS helped prepare federally and State-inspected small and very small plants to implement HACCP through the following initiatives:
Network of contacts and coordinators
Office of the Coordinator established.
Demonstration workshops
Materials
Mentor program
Implementation meetings
Generic models and guidebooks
Model HACCP plants
Correspondence and one-to-one interaction
Self -study packages
HACCP hotline
In October 1999, FSIS released a progress report on its first 6 months of testing for Salmonella in raw meat and poultry products. The progress report, which covered January 26, 1999, through July 30, 1999, presents data for broilers, swine, and beef in large plants and data for broilers and ground beef in small plants. The results showed continuing progress in significantly reducing the prevalence of Salmonella. These results can be found in the Enhanced Scientific Activities section of this report.
In October 1999, FSIS began the pilot-testing phase of a new inspection models project. The project is an effort to more fully integrate the principles of a science-based, preventive food safety system into slaughter operations and to determine if this new system is at least as effective as--or better than--the current inspection system.
Up to 30 plants that slaughter young, healthy animals are participating in this nationwide test. Goldkist, Inc., Guntersville, Alabama; Hatfield Quality Meats, Inc., Hatfield, Pennsylvania; and Quality Pork Processors, Inc., Austin, Minnesota, were the first plants to test the new procedures. Goldkist, Inc., slaughters young chickens, while the other two plants slaughter market hogs.
During FY 1999, FSIS began developing in-distribution inspection models under which it will redeploy some inspectors currently assigned within plants to verify the safety and wholesomeness of meat and poultry products after they leave the plant. As the pilot progresses, these inspectors will perform in-distribution as well as in-plant activities, thus testing the concept of more fully integrating the two segments of the farm-to-table chain.
On May 19, 1999, FSIS and the National Joint Council (NJC) reached an agreement involving the HACCP-based inspection models project. The memorandum of understanding allowed the Agency to proceed with implementation of the models testing phase of the HACCP slaughter models project.
On September 21, 1999, NJC filed a lawsuit against USDA to prevent the implementation of the models project. On September 23, 1999, the District of Columbia Federal District Court ruled in favor of USDA, affirming USDA’s authority to implement the project.
FSIS began conducting a risk assessment for E. coli O157:H7 in ground beef and carcass trimmings. The risk assessment will estimate the risk of foodborne illness from E. coli 0157:H7 both with existing programs and practices and with alternative mitigation strategies. FSIS is exploring whether further changes are needed in its policy regarding E. coli O157:H7 in light of new information that is emerging about the pathogen and its relation to human health. FSIS will re-evaluate its policy on E. coli O157:H7 through an open, participatory process, soliciting input from all of its various constituents.
Throughout FY 1999, establishments were reminded that adulterated meat products are prohibited from being distributed in commerce. Ready-to-eat dry and semidry sausages tested under this program found to be adulterated are subject to such Agency action as may be required to protect public health, including detention, seizure, and recalling of product. The project is ongoing.
On September 7, 1999, FSIS began using a more sensitive method for detecting E. coli O157:H7 in raw meat products. The new method is approximately four times more sensitive than previous methods, greatly increasing the probability of detecting very low levels of the potentially dangerous pathogen. The new testing method, called "immunomagnetic separation" (IMS), will be incorporated into the standard procedures in use at all three FSIS field service laboratories, located in Athens, Georgia; Alameda, California; and St. Louis, Missouri.
To better ensure the safety of the Nation’s food supply, in January 1999, FSIS published a Federal Register notice clarifying its policy regarding raw beef products contaminated with the E. coli O157:H7 pathogen.
Also in January 1999, FSIS announced the availability of its revised guidance document "Guidance for Beef Grinders to Better Protect Public Health," which was first made available to the public in March 1998. It was not prescriptive, in a regulatory sense, but was intended to illustrate how grinding operators can avail themselves of opportunities to minimize food safety hazards associated with their products. FSIS intended the document to assist processors of ground beef, especially small processors, in developing procedures to minimize the risk of E. coli O157:H7 and other pathogens in ground beef products produced in their establishments. During FY 1999, it was modified to respond to the suggestions and comments by several organizations and to incorporate some details on rework and product recall plans derived from the guidance provided by the National Meat Association and the American Meat Institute. The updated version is available from the FSIS Docket Room, and can be downloaded from the FSIS Web site. Printed copies were sent to all grinding establishments.
In FY 1999, FSIS and FDA worked together on a Listeria monocytogenes (Listeria) risk ranking. FSIS and FDA expect to release a report on the risk assessment in 2000.
At the request of FSIS, USDA's Agricultural Research Service (ARS) designed a study to examine the prevalence of Listeria in a ready-to-eat product (hotdogs) supplied by volunteer plants over a 12-month period. Product will be held at a temperature representing typical retail storage and at an "abuse" temperature, and will be tested for the presence of Listeria at several time points over a 3-month period. ARS also proposed to subtype and enumerate bacteria in positive samples.
This study is expected to produce data that will address several important information gaps, including: the prevalence of contaminated products in the marketplace; the effect of "grow out" on detection of Listeria during shelf life; and counts of Listeria that actually occur in commercially packaged products over their shelf lives.
In May 1999, FSIS announced three near-term and four long-term initiatives to help industry control Listeria in ready-to-eat products and, thus, better protect public health. First, FSIS published a notice in the Federal Register advising plants to reassess their HACCP preventive control plans to ensure that the plans are adequately addressing the pathogen. Second, the Agency provided guidance to industry recommending environmental and end-product testing. Lastly, FSIS carried out extensive educational efforts targeted to "at risk" consumers -- pregnant women and newborns, older adults, and people with weakened immune systems caused by certain cancer treatments, AIDS, diabetes, and kidney disease.
FSIS developed the document "Listeria Guidelines to the Industry." This guidance document provided a detailed review of practices known or demonstrated to be effective in preventing the occurrence of Listeria in ready-to-eat products. This document was made available through the FSIS Web site and was sent to establishments along with the HACCP Generic Models publication, which is applicable to ready-to-eat products.
On February 10, 1999, FSIS held a public meeting to discuss the food safety issues related to Listeria in meat and poultry products. At this meeting, industry and government procedures were discussed, including sampling programs for ready-to-eat products and the best way to reach audiences particularly susceptible to foodborne illness with food safety information. Subsequent to the February 10, 1999, public meeting, the Agency embarked on the development of the "FSIS Action Plan for the Control of Listeria for the Prevention of Foodborne Listeriosis."
Today’s shift toward mass production and distribution of food, increased globalization of food trade, and changing consumer trends in eating habits makes identifying and tracking potential food hazards much more complex. Food safety has become a very important public health issue due a more susceptible population and the emergence of new pathogens and more virulent or antibiotic-resistant strains of known pathogens. Through the President’s Food Safety Initiative, FSIS is engaged in collaborative efforts to improve public health by partnering with other public health agencies and stakeholders. These efforts include:
Specific activities include:
During FY 1999, FSIS assisted numerous local and State health departments with investigations of foodborne illnesses. Actions included assisting States with: epidemiologic laboratory analysis, product traceback, identification of outbreak-related cases, recall of suspect product, and public notification of recalls. A brief summary of the major investigations follows:
An outbreak of listeriosis caused by the foodborne pathogen Listeria occurred from August 1998 to March 1999. In all, more than 101 people in 22 States were infected with this organism and, of those, there were 15 adult deaths and 6 miscarriages or stillbirths.
October 1998
November 1998
December 1998
As recently as a 1998, these incidents would have appeared as sporadic and unrelated cases scattered over numerous States. Instead, officials were able to determine it was an outbreak. This was due to the rapid information sharing between jurisdictions; reporting of data to the Centers for Disease Control and Prevention and FSIS; collaboration among government agencies to review the problem; standardizing data collection and coordination; and analyzing food and clinical isolates with modern molecular DNA testing methods.
As a result of this information sharing, officials were able to trace the outbreak to its source and take action against the plant. In May 1999, following an in-depth FSIS team review and evaluation of the plant’s food safety system, FSIS issued a Notice of Intended Enforcement Action to the plant. The determination to initiate enforcement was supported by repeated findings of Listeria in cooked ready-to-eat product produced by this plant. FSIS required clarification of certain parts of the plant’s written response in June 1999. The plant provided clarifying information, and FSIS held the suspension of inspection in abeyance.
In addition to the listeriosis outbreak, FSIS worked closely with field staff and State health departments to trace incidences of foodborne illness. Examples include the following:
October 1998
April 1999
July 1999
September 1999
Beginning in October 1997 and continuing into FY 1999, FSIS took the lead in a multi-Agency (FSIS, FDA, and CDC) investigation of rapid-onset nausea in school-aged children who had consumed burritos and pizza during school lunch periods. The incidents (gastrointestinal illness onset within 5 to 25 minutes of ingestion; and median duration of illness was 4½ hours) were reported in seven States, although largely focused in Georgia and Florida. A report summarizing the outbreaks was published in the Morbidity and Mortality Weekly Report [Outbreaks of Gastrointestinal Illness of Unknown Etiology Associated with Eating Burritos – United States, October 1997 – October 1998]. All samples tested negative except for low levels of mycotoxins and further investigation into mycotoxins is underway.
There were 12 contamination response system incidents between January and October 1999. The most important of these led to the condemnation of approximately 100,000 pounds of beef adulterated from co-mingling with a grand champion steer from an Ohio County Fair that had been treated with phenylbutazone, a drug that is not permitted to be used in food-producing animals.
The Consumer Surveillance Information System (CSIS) is designed to detect problems with meat, poultry, and egg products under jurisdiction through consumer complaints. The system logged 390 complaints in FY 1999. Cases entered into the CSIS database involve complaints alleging foreign materials contamination (42 percent), foodborne illness (52 percent), allergic reactions to unlabeled ingredients (3 percent), and other categories (3 percent). CSIS functions as an adjunct to the product recall process by locating potentially hazardous products already in the market that should be removed from commerce.
In 1998, a Food Emergency Rapid Response and Evaluation Team (FERRET) was established by the Secretary to provide a quick and appropriate USDA response across agencies to food safety emergencies. Participants are FSIS; Food, Nutrition and Consumer Services; Farm and Foreign Agricultural Services; Research, Education and Economics; Marketing and Regulatory Programs; the General Counsel; the Inspector General; and Office of Communications. The Secretary appointed the Under Secretary for Food Safety as Chair of FERRET. The emergency response activities are coordinated by FSIS. In 1999, FERRET developed a USDA plan for handling food emergencies, both unintentional and intentional in nature. FERRET will continue to coordinate USDA's responses to food emergencies.
FSIS held the dedication of its state-of-the-art Technical Service Center (TSC) in Omaha, Nebraska, on May 21, 1999. Omaha was selected for the TSC because of the availability of suitable office space, the area’s ability to attract future employees, a diverse work force, and air transportation services. The move served as an excellent example of how locating Federal agency offices in downtown areas can help to promote economic development.
In July 1999, the Administrator formed the Workforce of the Future Steering Committee (WOFSC) to coordinate key program and policy initiatives to ensure that the FSIS workforce can support the food safety systems of the future.
The Steering Committee includes two full-time employees, plus representatives of all FSIS program areas, the National Joint Council of Food Inspection Locals, the National Association of Federal Veterinarians, and the Association of Technical and Supervisory Professionals. The Committee includes field and headquarters employees, representatives of the FSIS major occupations, and representatives of various ethnic groups. The WOFSC has held two full meetings (October 1999 and March 2000).
At the end of FY 1999, the Steering Committee had monitored the activities of about 20 initiatives, projects, or functions with workforce planning implications. This monitoring ensures that Agency initiatives are in accord with the Workforce of the Future's guiding principles. The overarching goals of these guiding principles is to ensure consistency in Agency decision-making, procedures, and communication and to maintain employee support for the transition to the workforce of the future.
On August 5, 1999, FSIS Administrator Thomas Billy announced the formation of an FSIS Training and Education Committee (TEC-2001) that will conduct a comprehensive examination of the Agency’s training and education needs for the coming years.
In support of the FSIS mission, the Committee will develop a program designed to ensure a well-educated, competent FSIS workforce, and explore and establish educational partnerships in the community FSIS serves, including other Federal agencies, State agriculture and public health departments, the international trading arena, industry, and consumer groups. In addition, the Committee will explore technology-based approaches to training delivery, such as distance learning.
All FSIS employees, including employee organizations, as well as other stakeholders who share the Agency's interest and commitment to food safety will be solicited for input into this program. The wealth of experience from these groups beyond the Agency will ensure that all interests are represented.
In April 2000, FSIS launched the pilot phase of its new leadership development initiative: the Management and Leadership Development Program (MLDP). The primary goal is to facilitate the transition from a command and control orientation in supervision and management to one of collaboration and conflict management. This change is necessitated by the introduction of HACCP and other trends in the contemporary business environment.
Eventually, the MLDP will be open to virtually all employees. Phase one, however, is limited by necessity to members of designated workgroups. MLDP participants may enroll in a number of FSIS leadership courses, including collaboration in the workplace, coaching skills, conflict management, how to conduct effective meetings, and how to conduct briefings. Following phase one, the project will be evaluated to determine the extent to which Agency investment in the MLDP actually produced job-related behavioral improvement.
All 25 State programs were reviewed during FY 1999. Rigorous comprehensive reviews of seven of the State programs were initiated and will be completed in FY 2000. Each State program receives a comprehensive review every 3 to 5 years.
In February 1999, USDA hosted the National Federal-State Food Safety Conference, inviting the senior food safety officials in each State. All 50 States and Puerto Rico sent senior representatives, including 24 Secretaries of Agriculture and seven Secretaries of Health.
In April 1999, FSIS hosted the annual conference of the FSIS/State Meat and Poultry Inspection Directors. Issues discussed included: animal production food safety issues; model standards for State meat, poultry and egg programs; implementation of HACCP in small and very small plants; the in-distribution inspection pilot test project; in-plant HACCP models for processing and slaughter; the recall process; the Salmonella testing program; comprehensive reviews; and revision of FSIS Directive 5720.2 on Cooperative Inspection Programs.
The goal, which by all accounts was attained, was to generate support among these key State officials for FSIS' national food safety initiative involving all levels of government. The conference increased State officials’ knowledge about the Administration’s food safety resources, national agenda, and strategic planning initiative; encouraged States to make food safety a priority; and developed working relationships to foster the integration of Federal and State food safety activities.
The agenda included speeches by then-Agriculture Secretary Dan Glickman, then-Health and Human Services Secretary Donna Shalala, Richard Pombo, Chair, U.S. House of Representatives Subcommittee on Livestock and Horticulture, and Collin C. Peterson, Ranking Minority Member, U.S. House of Representatives Subcommittee on Livestock and Horticulture. A number of USDA and HHS agencies participated. In addition, a mock outbreak exercise was facilitated by USDA's Animal and Plant Health Inspection Service.
Recognizing the key role that State and local government agencies play in a seamless national food safety system, in September 1999, FSIS launched a Regulators' Food Safety Information Line (1-800-233-3935). Located at FSIS' Technical Service Center in Omaha, Nebraska, the site of the successful HACCP Hotline, the service answers food safety questions related to meat, poultry, and egg products. The information line is expected to improve cooperation and communication at all levels of government and to provide timely, authoritative answers to State officials.
On November 4, 1999, FSIS and the Association of Food and Drug Officials (AFDO), along with FDA's Center for Food Safety and Applied Nutrition, hosted the fourth in a series of educational broadcasts on the potential health risks of meat and poultry produced at retail stores and restaurants. The purpose of the broadcasts was to provide training to State, local, and tribal sanitarians on processes and procedures used in USDA-inspected facilities that can be applied to retail stores and restaurants.
To help laboratories become more integrated, six workgroups were formed under the National Integrated Food Safety System (50 States Program) and met for the first time in December 1998. The project's three goals are to lead a national movement toward laboratory accreditation under international acceptance standards (ISO standards 17025); to implement a pilot project to efficiently document and validate modified and new analytical methodology; and to promote data exchange. In 1999, eight Federal, State, and local laboratories began a pilot project in which information is shared among the participating laboratories.
Nineteen States have partnered with FSIS to promote awareness and implementation of food safety and good production practices to reduce the risks of chemical, physical, and where appropriate, microbial hazards in live animals. The objective of the projects is to improve animal health, quality assurance, and food safety by promoting the voluntary adoption and awareness of HACCP-compatible practices from the farm to slaughter.
FSIS entered into contracts with eight tribal colleges to educate under-served producers and very small plants on HACCP.
As a result of the USDA Civil Rights Action Team (CRAT) report released in February 1997, the Department required its agencies to provide multi-year civil rights and Equal Employment Opportunity training to all employees, beginning in FY 1998. In FY 1999, FSIS continued to improve its civil rights record.
FSIS continued to meet the USDA mandate to provide multi-year civil rights and EEO training to all employees. During FY 1999, the Agency completed the first component by providing basic EEO training to all field personnel. In addition, 1,800 non-bargaining unit employees received two new training components, Program Delivery and Sexual Harassment. FSIS finalized plans with the National Joint Council to deliver these components to more than 7,000 bargaining unit employees during FY 2000.
The agency conducted its first Diversity Conference in September 1999. Approximately 150 supervisory and nonsupervisory personnel attended the conference. A variety of workshops addressed many employment and civil rights issues that have an impact on the agency's goal of achieving and maintaining a diverse workforce.
Two town hall meetings were held in 1999 to enhance communication on civil rights matters. The meetings addressed civil rights accountability and disability awareness. Headquarters and field personnel participated via audio conference. At the meeting on disability awareness, the TARGET (Technology, Access, Resources, Gives Employment Today) Center demonstrated products that aid the disabled in their daily duties.
This year, the Agency employed more than 55 students under various employment programs, including the Hispanic Association of Colleges and Universities Summer Intern Program, the Washington Internship for Native American Indian Students, the USDA 1890 Scholars Program, the DC Federal Job Initiative, and the Minorities in Agriculture, Natural Resources, and Related Sciences Program. The goal of each program was to help build and diversify the applicant pool.
Voluntary Dispute Intervention Program's Second YearDuring its second year, the Voluntary Dispute Intervention Program (VDIP) added additional services. Some of the services, such as conciliation, are voluntary. Others, such as team problem solving, fact-finding and facilitation, are required rather than voluntary. An explanation of these additional services follows:
Team Problem Solving (TPS). This is a facilitated multi-party process involving several employees at the same or various grade levels working together to solve a problem. TPS has been used successfully in Field Operations for a number of years. Recently, several requests for TPS were initiated though VDIP. VDIP mediators led or participated in three TPS sessions. All resulted in the implementation of action plans.
Facilitation. A facilitator, who is a neutral participant, usually helps to conduct meetings or coordinate discussions among participants at a meeting. FSIS facilitated five such meetings through VDIP.
Conciliation. This is a process in which a neutral third party tries to bring the disputants to an agreement by lowering tensions, improving communications, interpreting issues, and providing technical advice. FSIS conducted four conciliation sessions and is conducting one for another USDA agency.
Fact-Finding. This is a process whereby a neutral third party gathers preliminary information in an effort to determine what additional Alternative Dispute Resolution method(s) could help correct a problem or issue. FSIS conducted one fact-finding session.
During FY 1999, VDIP had 6 mediators at headquarters and 16 in the field. VDIP conducted 26 mediations resulting in 20 agreements during FY 1999. About one-third of these mediations related to EEO issues. During this period, none of the agreements resulted in monetary payments. VDIP also conducted two facilitations during this period that led to the implementation of action plans.
During FY 1999, the Technical Service Center's Review Staff developed a special review methodology, and revised and updated both data-gathering forms and the format for in-plant assessment of State meat and poultry inspection programs. These revisions were necessary because of the implementation of Pathogen Reduction and HACCP regulations in State programs. During FY 1999, 96 State-inspected establishments were reviewed in 9 States. Special reports prepared by the Review Staff provided detailed information to the Federal-State Relations Staff for evaluation of the effectiveness of State inspection programs, and assisted in determining the "equal-to" status of State-managed meat and poultry inspection programs.
The staff provided special guidance and consultant service to a variety of organizations, including the Kansas and Minnesota State Inspection Programs, the Office of Inspector General, during the audit of HACCP implementation in large establishments; and to meat inspection officials from Malaysia, Hong Kong, France, Taiwan, Canada, Mexico, Russia, and the European Union, who were escorted on official tours of Federal establishments.
In FY 1999, FSIS completed the fourth full year of an agreement with the Centers for Disease Control and Prevention to conduct active population-based surveillance for foodborne diseases (Campylobacter, E. coli 0157:H7, Listeria, Salmonella, Shigella, Vibrio, Yersinia, Cryptosporidium, and Cyclospora) in Minnesota, Oregon, and selected counties in California, Connecticut, Georgia, Maryland, New York, and Tennessee (total population: 30 million). This multi-year study is providing much needed data regarding the burden of foodborne illness in the United States. The Food and Drug Administration and the Environmental Protection Agency are also partners in this effort.
FoodNet includes active surveillance for diseases caused by foodborne pathogens, case-control studies to identify risk factors for acquiring foodborne illness, and surveys to assess medical and laboratory practices related to the diagnosis of foodborne illness. FoodNet is providing better estimates of the burden of foodborne illness and sources of specific diseases that are usually foodborne in the United States. FoodNet tracks and interprets trends in these diseases over time. The baseline and annual data are being used to document the effectiveness of the HACCP rule in decreasing the number of cases of major bacterial foodborne disease in the United States each year.
The following are key findings based on recently released estimates from CDC:
The overall burden of food-related illness in the United States is great. FoodNet estimates that 76 million cases of foodborne illness occur per year, resulting in approximately 325,000 hospitalizations and 5,000 deaths.
In 1999, FoodNet conducted population-based active surveillance for confirmed cases of Campylobacter, E. coli 0157:H7, Listeria, Salmonella, Shigella, Vibrio, Yersinia, Cryptosporidium, and Cyclospora in Connecticut, Georgia, Minnesota, Oregon, and selected counties in California, Maryland, New York, and Tennessee. Campylobacter was the most frequent cause of sporadic cases of foodborne illness, even though outbreaks caused by this pathogen are rare. In FY 1999, FoodNet began a study of Campylobacter infections to identify control points and direct future prevention strategies.
FoodNet showed that E. coli 0157:H7 infections were more commonly diagnosed in Northern States and that undercooked ground beef was the principal food source of E. coli 0157:H7 infections. In contrast with the findings of previous investigations, hamburgers eaten at fast food restaurants were not associated with infections, suggesting that changes in that industry may have reduced E. coli 0157:H7 infections from that source. A new case control study of E. coli 0157:H7 began in 1999.
Hospitalization associated with foodborne diseases is an important public health burden, and is involved in 16 percent of confirmed infections detected by FoodNet. In FoodNet sites, Listeria infections had the highest hospitalization rate at 90 percent and caused nearly half of the reported deaths. Because of this, FoodNet designed and began additional studies of Listeria infections in 1999 to identify food sources and potential control points. This study is planned for 2 years to ensure that an adequate number of cases are included.
FoodNet conducted case-control studies of Salmonella infections. Eating chicken and undercooked eggs was associated with sporadic Salmonella Enteritidis and Salmonella heidelberg infections. In-depth analyses of these studies are nearing publication.
FoodNet piloted electronic reporting of foodborne outbreaks of any cause within the sites in 1999.
The 1998 FoodNet Surveillance Results report a decline in the incidence rate of salmonellosis over the period 1996 to 1998. FoodNet 1998 data show that salmonellosis decreased 14 percent, which was particularly pronounced for the Enteritidis strain. Ongoing, active, laboratory-based surveillance is being used to document the effectiveness of new food safety control measures, such as HACCP, in reducing the number of cases of foodborne diseases in the United States.
PulseNet is a national computer network of public health laboratories that helps to rapidly identify and contain outbreaks of foodborne illness. The laboratories perform DNA "fingerprinting" on bacteria that may be foodborne, and the network permits rapid comparison of these "fingerprint" patterns through an electronic database at the CDC. PulseNet is an early warning system that links seemingly sporadic human illnesses together, and, as a result, more outbreaks can be recognized, especially those that involve many States. For example, in FY 1999, PulseNet contributed to the detection and investigation of a large, multi-State outbreak of listeriosis. Investigation of these outbreaks should result in the identification of hazards and implementation of new measures to increase the safety of the food supply.
FSIS data indicate that the prevalence of Salmonella in meat and poultry products parallels the decreased salmonellosis incidence seen in human populations. FSIS data came from the sampling of four product categories: broiler carcasses, swine, ground beef, and ground turkey. These samples were taken from January 26, 1998, through January 25, 1999, from about 200 large plants. The results were compared with the prevalence found in baseline studies conducted before FSIS instituted the HACCP rule in meat and poultry slaughter and processing plants. The FSIS results are considered preliminary and do not represent a random sample of all domestic meat and poultry production.
In broiler carcasses, the rate of Salmonella prevalence dropped from 20 percent to 10.9 percent, a decrease of nearly 50 percent. Swine carcass contamination dropped from 8.7 percent to 6.5 percent. Ground beef positive samples dropped from 7.5 percent to 4.8 percent and ground turkey Salmonella rates dropped from 49.9 percent to 36.4 percent. Although FSIS does not attribute these reductions solely to the implementation of HACCP, the results are encouraging.
For more than a decade, FSIS has been conducting the Nationwide Microbiological Baseline Data Collection program to identify and count pathogenic bacteria and indicator organisms on meat and poultry produced under Federal inspection. The establishment of baseline profiles for meat and poultry will provide a yardstick for measuring the effectiveness of changes over time. The studies include testing for the presence of Salmonella, E. coli 0157:H7, and several other pathogens in beef, pork, and broiler chicken carcasses, and in raw ground meat and poultry products.
In FY 1999, FSIS began baseline sampling of raw chicken carcasses for Campylobacter, which were to be completed in late 2000. The resulting data will be used to assess the need for an industry performance standard for Campylobacter under HACCP.
Since 1987, FSIS has conducted monitoring programs for the presence of Listeria and Salmonella in cooked, ready-to-eat meat and poultry products. Because proper cooking should destroy this pathogenic bacteria, FSIS takes regulatory action if these organisms are found in fully cooked, ready-to-eat product. FSIS' actions can include retention, detention, or recall of product, with subsequent intensified sampling of product produced at the implicated plant. In FY 1999, FSIS continued monitoring programs for these organisms in meat and poultry products. A total of 6,797 product lots were analyzed for Listeria, with 186 positive lots detected. Salmonella was detected in 25 of the 6,088 product lots analyzed.
In FY 1999, under the monitoring program for E. coli 0157:H7 in cooked meat patties, FSIS tested 8,710 total raw ground beef samples with 20 from imported products, 4,700 from federally inspected establishments, 3,943 from retail, and 47 from State-inspected establishments. Of these, 29 samples were confirmed positive for E. coli 0157:H7, 19 samples from federally inspected establishments and 10 samples taken at retail. The program was to continue for a sixth year in FY 2000.
The monitoring programs for Listeria, Salmonella, and E. coli 0157:H7 are continuous and the number of samples analyzed increased in FY 1999 by 4,960.
In FY 1999, FSIS continued monitoring manufacturing practices and production of dry and semi-dry ready-to-eat fermented sausages by way of analyzing the finished product for Staphylococcus aureus enterotoxins. Improper fermentation may result in the growth of staphylococci and potential formation of enterotoxin, which poses a human health hazard. In FY 1999, a total of 397 samples were analyzed, with no samples testing positive for staphylococcal enterotoxin.
In FY 1999, FSIS conducted 35,993 Swab Tests on Premises (STOP) to detect the presence of antibiotics in meat and poultry. During FY 1999, 5,582 Calf Antibiotic and Sulfa Tests (CAST) were conducted to detect antibiotics and sulfa drugs in bob veal calves. The Fast Antimicrobial Screen Test (FAST) was developed in 1991 to replace CAST and STOP. It detects both antibiotics and sulfonamide drug residues in animal tissues. Analysis indicates that the FAST test is as accurate as the STOP and CAST tests. In FY 1999, FSIS conducted testing of 125,534 samples using the FAST procedure.
FSIS served as the scientific advisor to the Department of Agriculture's Office of the General Counsel in a multi-Agency (Department of Agriculture, Environmental Protection Agency, and Department of the Interior) investigation of toxic-level Selenium (Se) exposures in cattle grazed on Federal lands in the Northwestern United States. More than 60 years ago, Se toxicity (liver damage, teratogenicity, embryotoxicity) was diagnosed in various animal species that were known to consume certain plants that accumulated Se. Recent cases of Se toxicosis were identified in several horses, and it is suspected in the deaths of a number of sheep that had been grazing on, or adjacent to, several reclaimed phosphate strip mine sites in the Western United States. Studies are currently in progress to determine the levels of Se in the local environment and in potentially exposed wild and domesticated animals. Food safety concerns focus on the potential for elevated Se levels in livestock (cattle and sheep) grazed on reclaimed mine sites that were slaughtered for food use.
Dioxins are a group of carcinogenic compounds that may be present in the environment because of manufacturing processes or from the combustion of a specific group of pesticides and related compounds. During FY 1999, a large animal feed contamination incident occurred in Belgium. The feed was found to be contaminated with both dioxins and polychlorinated biphenyls (PCB). Because the United States imports meat and poultry products from the European Union, FSIS instituted a program to screen for dioxins, using elevated PCB concentrations as a trigger for further analysis for dioxins. Four of approximately 750 samples had elevated PCB concentrations and were analyzed for dioxins. The samples tested negative for dioxins.
In September 1999, Japan informed FSIS that it had found a fat sample from a rib-eye roll to contain an elevated level of dioxins. FSIS conducted a small, focused study of cattle, and all samples were found to be negative for elevated levels of dioxin.
In FY 1999, FSIS completed the fourth phase of the 5 year nationwide Field Automation and Information Management (FAIM) initiative, and began extending the FAIM project to include the State meat and poultry inspection programs. The full installation of FAIM will facilitate a more scientific and uniform nationwide inspection program.
During FY 1999, 760 computers were delivered to Federal inspectors in Florida, Illinois, Kentucky, Michigan, Ohio, West Virginia, and Wisconsin, and approximately 800 inspectors were trained. At the end of the fiscal year, FAIM was fully implemented in 13 of FSIS’s 17 District Offices. By the end of FY 2000, FAIM will be operational in all 17 District Offices.
Also during FY 1999, FAIM implementation began in 14 States with State Inspection Programs, with more than 500 computers being delivered and approximately 550 State inspectors being trained. Arizona, Delaware, Minnesota, Mississippi, South Carolina, Texas, and Vermont completed FAIM implementation in FY 1999. It is anticipated that several additional years will be needed to fully implement FAIM in all of the State programs.
Since the initiative began, a total of 4,000 computers have been delivered to Federal and State inspectors, and more than 5,100 inspectors have been trained. During FY 1999, 71 percent of the total number of computers to be delivered (both Federal and State) were delivered, and 74 percent of the inspectors to be trained were trained.
To support the implementation of new software applications, computer-based training (CBT) courses for Word 97, Excel 97, Outlook 98, and Electronic Forms were delivered to all FAIM-trained Federal inspectors. Approximately 3,000 inspectors received FAIM training via CBT courses on CD-ROM’s.
In FY 1999, FSIS upgraded Automated Data Processing technology and telecommunications technology to maximize the productivity of the field workforce.
In a major step forward, the Agency’s antiquated HPDesk mail system was replaced at the field level by Microsoft’s Outlook 98 Exchange electronic mail system. The change required the conversion of over 3,000 HPDesk users to Outlook98 Exchange in approximately 4 months using computer-based training (CBT) provided via CD-ROM. All electronic mail users in FSIS are now using Outlook98 Exchange.
The implementation of the wide area network (WAN) to link FSIS field sites to Washington, DC, was also completed during FY 1999 – further enhancing communications between offices and field personnel. In locations where other USDA Agencies have existing circuits, FSIS entered into sharing arrangements to support the Department's enterprise network and reduce costs.
These improvements, taken together with earlier hardware and software upgrades, are providing FSIS with 21st century communications capabilities that can support the further modernization of meat, poultry, and egg inspection. The basic infrastructure for highly effective program management is rapidly being established.
In FY 1999, FSIS continued its regulatory reform initiatives to: (1) improve food safety; (2) make regulations less burdensome and easier to use; (3) make regulations more consistent with the HACCP rule; and (4) eliminate outdated regulations.
Many of FSIS' existing regulations are written in a command and control format, consisting of the specific steps that must be taken to meet FSIS' regulatory requirements. These regulations are inconsistent with HACCP and represent a regulatory burden to industry. The command and control format provides inadequate incentives and flexibility for meat and poultry plants to address the most significant food safety hazards in innovative ways.
In January 1999, FSIS converted into performance standards the regulations governing the production of cooked beef, roast beef, cooked corned beef products, fully and partially cooked meat patties, and certain fully and partially cooked poultry products. Unlike the previous requirements for these products, which mandated step-by-step processing measures, the new performance standards spell out the objective level of food safety performance that establishments must meet. The performance standards allow establishments to develop and implement processing procedures customized to the nature and volume of their production.
On August 30, 1999, the U.S. District Court for the District of Columbia ruled in favor of the USDA and then-Secretary Glickman and granted the Motion to Dismiss the lawsuit brought against the Department and the Secretary by James V. Hurson Associates, Inc. The lawsuit challenged the new labeling procedure, announced in the Federal Register in July 1998, which eliminated routine, daily, time-set, face-to-face appointments with label courier and expediting firms.
FSIS published a final rule in October 1999 to update sanitation regulations for official meat and poultry establishments. The rule converts many highly prescriptive sanitation requirements to performance standards, while streamlining and consolidating sanitary regulations applicable to both official meat and poultry establishments.
On December 23, 1999, FSIS published a final rule to streamline the approval process for food ingredients by ending the requirement that they be approved separately by both the Food and Drug Administration and FSIS. Previously, once the Food and Drug Administration approved a food ingredient, FSIS had to conduct separate rulemaking in order for it to be approved for use in meat or poultry. The rule, Food Ingredients and Sources of Radiation for Use in the Preparation of Meat and Poultry Products, became effective on January 24, 2000.
In FY 1999, FSIS provided a variety of services to help industry comply with HACCP guidelines. This assistance came in various forms, including: establishing a HACCP Coordinator's office; offering mentoring, guidebooks, self-study packages, demonstration workshops; providing a list of HACCP contacts and coordinators in all 50 States; offering tours of model HACCP plants; sending letters to remind plants of upcoming implementation dates; and providing a toll-free HACCP hotline to answer questions 24 hours a day.
Sixteen public meetings were held in FY 1999 to discuss FSIS policies, procedures, and issues such as HACCP implementation, the HACCP-based inspection models project, the Agency's E. coli O157:H7 policy, and the Agency’s Listeria strategy. Two technical conferences on HACCP implementation were held in August and December 1999.
The FSIS Web site, www.fsis.usda.gov, is a valuable resource for consumers, food safety educators, the regulated industry, FSIS employees, government officials, and other professionals. The site contains thousands of documents, including the Agency’s news releases, information on meat and poultry product recalls, sections on HACCP implementation, speeches by FSIS officials and the Under Secretary for Food Safety, regulations and directives, Agency reports and issuances, and career and employment information.
The Web site has become an integral part of FSIS’ publication distribution process. Consumer publications, employee newsletters, and educational materials may be downloaded in a variety of electronic formats. Visitors to the site may also view video clips including news releases and public service announcements.
The Web site now offers a number of electronic mail addresses that allow visitors to submit questions and comments to various programs and staffs within the Agency. In FY 1999, the most heavily used of these mailboxes, fsis.webmaster@usda.gov, received nearly 1,200 inquiries.
FSIS introduced a new, business-friendly Web site providing detailed labeling information to meat and poultry plants. The site provides essential information on labeling standards, policies, and procedures, including a special section that captures the small business issues. FSIS strives to ensure that small and very small meat and poultry processors are not at a disadvantage in accessing labeling requirements and gaining label approvals. The Web site has all of the information needed to help small food processors with technical and procedural labeling concerns, including the name of the Agency staff liaison charged with facilitating resolution of small business issues on a one-on-one basis.
The USDA Meat and Poultry Hotline provides answers to specific consumer questions on a wide variety of food safety issues. The hotline received 110,805 calls during FY 1999. In addition to basic food handling, storage, and preparation questions, the Hotline addressed issues including outbreaks of foodborne illness; pathogens such as Listeria, Campylobacter jejuni, and E. coli O157:H7; recalls of meat and poultry products; egg safety; dioxin contamination in Europe; Y2K food supply concerns; and the safety of cookware in microwave ovens.
FSIS began a multi-year campaign to promote food thermometer use by directing focus group testing of slogans and a representative character; planning activities for a campaign rollout in 2000; developing materials for a variety of media; and facilitating meetings and information exchange among the Food Temperature Indicator Association, an alliance of manufacturers. Additionally, several large grocery store chains launched their own thermometer promotions during FY 1999.
In September 1999, in observance of National Food Safety Education MonthTM, Secretary Glickman, then-Secretary Shalala, and Neal Lane, representing the President's Council on Food Safety, signed a proclamation to recognize the "many educators and consumers who actively promote safe food products and the safe handling of food." Under Secretary for Food Safety Catherine Woteki visited a local Washington, DC, area elementary school and demonstrated the use of thermometers to check for safe internal temperatures.
In FY 1999, the Partnership for Food Safety Education, a public-private partnership, continued its Fight BAC!™ campaign to educate Americans about safe food handling practices. In coordination with the Fight BAC!™ campaign, the Partnership developed and distributed a new curriculum for fourth through sixth grades, "Your Game Plan for Food Safety." FSIS provided support, review, and distribution for the new curriculum and the first "Presenters' Guide" for kindergarten through third grade. FSIS also supported the distribution of 30,000 copies of the Fight BAC! ™ brochure through the Federal Consumer Information Center in Pueblo, Colorado, and coordinated use of the BAC costume at school events, public health fairs, and conventions. In an other effort to educate consumers, FSIS supported the development and distribution of the multimedia materials—"Virtual Toolkits"—offered by the Partnership through the Fight BAC!™ Web site.
Senator Tom Harkin (D-IA) and Congressman John Baldacci (D-ME) each introduced legislation, S. 18 and H.R. 983, the Safe And Fair Enforcement and Recall (SAFER) for Meat and Poultry Act, that was developed by the Secretary and forwarded to Congress. The bill would amend the Federal Meat Inspection Act and the Poultry Products Inspection Act to provide for improved public health and food safety through enhanced enforcement. Both Members previously introduced this bill in the 105th Congress (FY 1998) as the Food Safety Enforcement Enhancement Act of 1998.
FSIS Administrator Thomas Billy, FSIS Associate Administrator Margaret O' K. Glavin, and other Agency officials testified before Congressional Committees and briefed Members and Committee Staff on many issues including the FY 2000 Budget, country of origin labeling, Y2K food safety and supply preparedness, the irradiation of meat and poultry products, the interstate shipment of State-inspected meat and poultry products, HACCP implementation, the possibility of a single food safety agency, egg safety, hormone-treated beef, and the mandatory inspection of non-amenable species.
FSIS continued responding to Congressional mandates by preparing and forwarding the following reports to Congress:
In November 1999, Senator Thomas Daschle (D-SD) introduced the Department’s bill, S. 1988, The New Markets for State-Inspected Meat Act of 1999. The key objective of the bill is to ensure that all meat and poultry products produced in the United States are inspected under a seamless national system enforcing a single set of requirements and eliminating the prohibition on the interstate shipment of State-inspected meat and poultry products.
The Conference Report accompanying the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 1999, directed USDA to conduct a study on the potential effects of mandatory country-of-origin labeling on imported fresh muscle cuts of beef and lamb. The Agency prepared and delivered the report, which addresses the costs and benefits of country of origin labeling, in January 2000.
The report states that country-of-origin labeling is not a food safety issue, but a marketing tool for domestic beef and lamb producers. The report discusses the potential costs to industry and government, benefits to consumers and producers, international trade issues, and the voluntary labeling system now in place. It also discusses a variety of means by which the labeling program could be implemented. Should a mandatory country-of-origin labeling program be enacted, the report recommends that labeling be done in a manner consistent with U.S. international obligations and that labeling requirements be drafted in a way that minimizes industry costs.
The Council, jointly chaired by Agriculture Secretary Glickman, Health and Human Services Secretary Shalala, and Neal Lane, the President's science advisor and Director of the White House Office of Science and Technology Policy, was involved in two major activities during FY 1999. First, it began developing a comprehensive strategic plan for Federal food safety activities to help Federal agencies address food safety challenges. Second, it began developing a coordinated food safety budget that will fully integrate the budget process among the various agencies with food safety responsibilities. The Council also provided the President with a response to the 1998 National Academy of Sciences’ food safety system study.
To develop the strategic plan, which was due to the President by July 2000, food safety officials worked together during the last 6 months of 1999 delineating a vision and core goals.
Continuing their joint efforts to combat foodborne illness, FSIS and the Food and Drug Administration, in June 1999, announced three important new measures to prevent illnesses attributed to contaminated eggs. The Food and Drug Administration proposed to require safe handling statements on labels of shell eggs to warn consumers about the risk of illness caused by Salmonella. In addition, for the first time, there is a uniform Federal requirement that all eggs and egg products packed for consumers be refrigerated at 45 degrees or below.
In addition, in June 1999, FSIS issued a directive applying the refrigeration requirement to warehouses and other distribution locations that store shell eggs packed into containers destined for consumers, including transport vehicles.
Working with the President’s Food Safety Council, on February 23, 1999, FSIS and the Food and Drug Administration signed a Memorandum of Understanding to facilitate the exchange of information at the field level about food establishments and operations that are subject to the jurisdiction of both agencies.
In June 1999, FSIS Administrator Thomas Billy was elected to a 2 year term as Chairman of the Codex Alimentarius Commission. Codex, established in 1962, is the major organization responsible for establishing international food standards. Through these standards, Codex protects the health of consumers and ensures fair practices in food trade. Codex, jointly sponsored by the Food and Agriculture Organization of the United Nations and the World Health Organization, is composed of 165 member nations, representing 98 percent of the world’s population.
In March 1999, FSIS made available a background paper explaining the process for determining whether exporting countries have meat and poultry systems and measures in place that are equivalent to the requirements of the Pathogen Reduction and HACCP rule. Only countries that have been certified as having equivalent systems are eligible to export to the United States. The availability of this document, titled "FSIS Process for Evaluating the Equivalence of Foreign Meat and Poultry Regulatory Systems," was published in the Federal Register on March 12, 1999.
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