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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 |
Pathogen Reduction/HACCP & HACCP Implementation
Draft, November 18, 1998
The Pathogen Reduction and Hazard Analysis and Critical Control Point (HACCP) systems final rule published in July 1996 calls for the establishment of a new food safety system intended to reduce the risk of food-borne illness from meat and poultry products. HACCP is a scientific approach in which processors control food production systems to prevent food safety hazards from occurring. Under HACCP systems, government is responsible for oversight and verification of industry's process control activities that provide for the production of safe food.
Under provisions of the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA), FSIS has authority to regulate the production, sale, transportation, and storage of meat and poultry food products. Traditionally, the Agency has assigned the great majority of its resources to inspection activities within livestock and poultry slaughter and processing plants. Consistent with the modernization and farm-to-table initiatives, FSIS intends to redistribute its resources in ways that permit FSIS to more efficiently and effectively verify that the industry meets its responsibility to produce safe and wholesome products.
The in-distribution (ID) inspection pilot tests discussed in this report are part of the HACCP-based Inspection Models Project. In a June 1997 Federal Register Notice, FSIS requested public comments on the design and development of new inspection models for livestock and poultry slaughter and processing in a HACCP environment (62 FR 31553). The notice summarized recommendations by the National Academy of Sciences and the General Accounting Office that FSIS reduce its reliance on organoleptic inspection, shift to inspection systems based on risk, and redeploy its resources in a manner that better protects the public from food-borne illnesses. To accomplish these objectives, inspection models must be developed that incorporate inspection procedures consistent with the pathogen reduction and HACCP systems rule. The inspection models project will help define what FSIS and the regulated industry will do in certain slaughter establishments operating under HACCP. A draft project protocol of July 7, 1998, identifies two objectives: (1) in the baseline phase, determine the effectiveness of the present inspection system in slaughter establishments by collecting and analyzing organoleptic and microbial data on livestock and poultry carcasses produced under the current system, and (2) in the models phase, test new inspection models at establishments where plant personnel perform slaughter process control and FSIS inspectors perform oversight and verification inspection activities and collect and analyze data to determine the effectiveness of the models and ensure the safety and wholesomeness of the products. One significant change in the project design since the July 7, 1998, draft is the reduction from 12 to 6 weeks of the period of microbial sample collection in both the baseline and model phases, with the number of samples to be collected remaining the same.
As of October 1998, five plants are participating in the project. They are Jennie-O Foods, Inc., Wilmar, Minnesota, a turkey plant; Hatfield, Inc., Hatfield, Pennsylvania, a swine plant; Rocco Farm Foods, Edinburg, Virginia, a poultry plant; Quality Pork Processors, Austin, Minnesota, a swine plant; and Goldkist Inc., Guntersville, Alabama, a poultry plant. Under a general contract with the Research Triangle Institute (RTI), baseline phase work began at Rocco on August 3 and at Hatfield on August 10. RTI is performing the baseline phase work for the three other plants as well. All baseline work at the five plants is scheduled to be completed by November 20.
A separate contract will be required to complete the models phase work for these five plants and to perform both baseline and models work for an estimated 30-40 plants that may choose to participate by volunteering for the project during FY 1999. The work will be performed over a two-year period (FY 1999 - FY 2000).
As part of the farm-to-table strategy, the in-distribution inspection pilot tests will help the Agency demonstrate the feasibility of significantly increasing the frequency of certain tasks that are now performed outside of federally inspected plants. The in-distribution pilots also will demonstrate how new activities can address food safety hazards and other consumer protection issues, such as economic adulteration or improper labeling, as meat and poultry products are transported out of plants into distribution channels, storage, retail food stores, restaurants, commercial kitchens, hotels, and other institutions.
Approximately 150 FSIS compliance officers now perform investigation, enforcement, and--to a lesser extent--inspection activities outside of plants. The inspection activities outside of plants may form the majority of activities performed by ID inspection personnel, thus allowing compliance officers to spend more time on investigative and enforcement work.
The following inspection activities are expected to form the majority of the work of ID inspection personnel:
In the United States there are hundreds of thousands of food-related businesses, such as warehouses, transportation companies, distributors, retail stores, restaurants, and caterers. A small percentage of these food-related businesses and a small percentage of businesses that handle animal byproducts, such as renderers, are reviewed each year. These reviews of food-related businesses and allied industries have been identified as inspection tasks to be performed by ID inspectors. A greater number of reviews will be performed when FSIS has ID inspectors available to perform this function.
Product sampling includes the routine collection of product samples of ground beef from retail stores for Escherichia coli O157:H7 testing, which is the only sampling program directed and managed by FSIS headquarters at this time. New activities may include collecting product samples to detect other microbes, undeclared species, preservatives, binders, and extenders. In-distribution inspectors may also collect product samples as part of a centrally directed economic testing program for national product surveys.
Following up on consumer complaints includes the collection of information from consumers after they have notified the Agency of a possible health, safety, or misbranding problem with a product. Consumer complaints may include allegations of foreign objects in meat and poultry products; illnesses from the consumption of meat or poultry products; and improper labeling of meat or poultry products.
Recall effectiveness checks are Agency efforts to verify the effectiveness of a plant's retrieval from distribution channels those meat or poultry products subject to recalls. Recall effectiveness checks include on-site visits to inspected establishments and other businesses to verify the accuracy of documents and the effectiveness of controls on product. Referring to lists of consignees who received the product, inspection program personnel then visit a certain percentage of the consignees to determine whether they received notification of the recall.
Educational activities include developing materials for presentations and presenting food safety awareness seminars to schools, civic organizations, consumer groups, religious institutions, and food pantries.
ID inspection personnel will collect data needed by the Agency to support other special efforts and future rulemaking, such as proposed standards for sanitation and temperature requirements during transportation and storage of meat and poultry. Two kinds of controls have been identified that would minimize the risk of food adulteration during transportation. One control is to ensure that products are not exposed to insanitary conditions. For example, risks of cross contamination from microbiological, chemical, or physical contaminants in transportation conveyances are high when the conveyances are not adequately cleaned before each new load. The second control is to ensure that products are maintained under conditions that will minimize the growth of pathogenic microorganisms that may be present, such as mechanisms to ensure that an appropriate temperature is maintained.
When violations are found or when product control actions are needed, in-distribution inspection personnel will collect preliminary data for follow-up actions by enforcement personnel. Investigations of possible criminal activities will continue to be handled by compliance officers. As is the case now, inspection personnel also may be called upon to assist compliance officers in their enforcement and investigation work. Such assistance with enforcement and investigative work may include taking samples of product in support of economic adulteration cases and conducting interviews and reviewing on-site records in connection with E. coli trace back investigations.
Attached is a chart showing the assignment of work for ID inspectors. In the ID pilot tests, circuit supervisors will supervise ID inspection tasks. As the chart illustrates, the district office issues work assignments to the circuit supervisor, who assigns the work to ID inspectors. Because many ID inspectors will perform both in-plant and ID inspection tasks, designating the circuit supervisor as the supervisor of ID inspectors prevents situations in which an inspector would have more than one direct supervisor.
ID inspection personnel will send routine results to a circuit supervisor, who will forward the data to the district office. ID inspectors will send reports of non-compliance directly to the assistant district manager for enforcement or a supervisory compliance officer, with a copy to the circuit supervisor.
The kind of work to be performed determines the job title, series, and grade of positions of employees performing food inspection tasks outside of plants. Position descriptions have been drafted for the ID inspection positions. However, design of the in-distribution pilots could not wait until issues involving job title were resolved. For the purposes of the ID pilot tests discussed in this report, the title of the new position will be that of consumer safety inspector, series 1862. However, a final decision on job title has not been reached. In this paper the term "ID inspector" is used to refer to an inspector who performs inspection tasks in distribution channels in addition to tasks in plants.
As is the case with the issue of job title, a final decision on the issue of grades has not yet been reached. However, for the purposes of these ID pilot tests, personnel performing ID inspection tasks will be in positions classified at grades 8 and 9. The ID inspection positions should be advertised at the GS-8/9 level because a relatively large pool of applicants--GS-7's, 8's, and 9's--will be eligible to apply. GS-8 is the developmental level before achieving the GS-9 journeyman level. Positions will be advertised at the GS-8/9 level, with promotion potential to the GS-9 "target" position. GS-9 ID inspectors will have more autonomy and require less supervision than GS-8 ID inspectors. Draft task categories (roles) and knowledge, skills, and abilities (KSA) also have been written. A task category is a specific function to be performed by an employee.
When not performing ID inspection tasks, inspectors selected for ID positions will be assigned to in-plant duties. Depending on the location of the assignment, some ID food inspectors may perform ID inspection tasks almost all of the time and only rarely perform in-plant tasks. A pilot test in an urban area would likely result in ID food inspectors performing ID tasks a great majority of their time. Other ID food inspectors will perform varying ratios of ID inspection tasks to in-plant inspection tasks. In the pilot tests, ID inspection work will be assigned in increments of parts of days, full days, and full weeks, with in-plant duties being performed during the balance of the time. When ID inspection tasks are permanently established, however, it is likely that the ratio of ID to in-plant inspection tasks will vary widely.
Many factors were considered in the development of the ID pilot tests. The agency has tentatively identified three separate locations for the ID pilot tests--the Philadelphia-Hatfield area; the Harrisonburg, Virginia, area; and an area that includes three circuits in Minnesota. The three locations were selected because they are also the locations of four of the in-plant models and because the three locations are examples of an urban area, a rural area, and a combination of an urban and rural area. In determining the number of ID inspectors to assign in each pilot, FSIS tentatively decided that one ID inspector--or one full-time equivalent--will be tested for each full-time compliance officer in that location, based on full staffing of compliance officers. This one-to-one ratio was chosen because it is manageable for pilot situations; the ratio does not have implications for the number of positions that will ultimately be located in an area.
In the Philadelphia-Hatfield, Pennsylvania, area, ID inspection tasks will be tested within three circuits--the North Philadelphia circuit, the South Philadelphia circuit, and the Hatfield circuit. The area is an urban location in which federally inspected establishments conduct mostly processing activities and in which there is a high density of retailers and other food handlers. Five ID inspectors are planned for the Philadelphia-Hatfield test.
A second pilot test in the Harrisonburg, Virginia, circuit calls for two ID inspectors in an area where federally inspected operations are approximately 50 percent slaughter and 50 percent processing and the number of retailers and other food handlers is not as great as in the Philadelphia-Hatfield area.
A third pilot test in three Minnesota circuits--St. Cloud; Austin; and Minneapolis-St. Paul--calls for three ID inspectors for a rural area in which federally inspected establishments conduct predominately slaughter operations and in which there are relatively few retailers and food handling businesses--except in the Twin Cities area. The three ID inspectors may perform inspection tasks anywhere within the three circuits.
At present, the Agency intends that the positions in which ID inspection tasks and in-plant inspection tasks will be performed will be advertised district-wide in one job announcement. The positions will be advertised as temporary, not to exceed 2 years, but may be extended beyond 2 years or made permanent without further competition.
The three ID inspection pilots are planned for locations where the HACCP slaughter inspection models will be tested. The following information summarizes the pilot tests; some details are subject to change, however.
When the Agency begins testing ID inspection at the three sites, information will be available almost immediately for use by the agency to continually evaluate and adjust the tests. Such information may include observations about the flow of work assignments and the effectiveness of communications between ID inspectors and district office personnel. The Agency also will test ID inspection tasks in new sites. Eventually, ID inspection in the test locations will evolve into a permanent system nationwide.
The system now available to support inspectors on patrol assignments and compliance officers can be used to provide administrative support for the new ID inspectors. Approximately 1,833 inspectors are now assigned to 2,336 processing inspection assignments. Many of the inspectors work patrol assignments in which they are responsible for an average of 4 to 6 processing plants. Inspection work on patrol processing assignments is similar in some ways to the ID inspection positions being established. That is, inspectors on patrol assignments work with minimum supervision and are responsible for making decisions about priorities. The administrative support needed by ID inspectors includes procedures for travel reimbursement, availability of government automobiles, and the issuance of laptop computers, pagers, cameras, and coolers for sample preservation.
A training program is being prepared for inspectors who will perform ID tasks. The agency is writing performance elements (knowledge, skills, abilities), which are needed to develop a training program. Because the tests will involve ID tasks and in-plant tasks, the ID performance elements will be combined with in-plant performance elements that already exist. Inspectors chosen for the three pilot tests will be trained together.
The elements of the training program are the orientation session, on-the-job training, formal training, and an evaluation by mentors and circuit supervisors
The orientation session will be attended by the food inspectors, the circuit supervisors of the test models, and the compliance officers who will serve as mentors to the ID inspectors. The ID pilot tests and the position of ID inspector will be explained to the participants. For example, it will be made clear that the positions are not compliance officer positions. The training steps will be outlined. The length of the orientation session has not yet been determined.
Each inspector will receive on-the-job training from one compliance officer who will also serve as a mentor. During a 2-week on-the-job training period, each trainee will accompany a compliance officer-mentor on his or her duties. Circuit supervisors included in the pilot test project will be encouraged to accompany the compliance officer during part of the on-the-job training to become familiar with the nature of ID work.
After the on-the-job training, the participants will received formal training, which will include workshops and acting scenarios similar to those given as part of the training for compliance officers.
The mentor and circuit supervisor will evaluate the trainee.
Assignment of Work for In-Distribution Inspectors (1-page flow chart): To view image, click on one of the thumbnails below.
(oriented for online viewing)
(Oriented for printing; should fit on 8-1/2 x 11 page if printed with no headers, footers, or extra margin)
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