In September, 1995, USDA's Food Safety & Inspection Service uncorked a 600-page document called the Top-To-Bottom Review. It represented a compilation of ideas and possible strategies the agency is considering as it reshapes the FSIS to become more responsive to meat and poultry inspection issues of the future, to address public health and safety concerns and deal with a diminishing operational budget. Many of these ideas would have a profound impact on you and your business.
The American Association of Meat Processors wants to share some perspectives on highlights and controversial aspects of the Review. Although circulated for comment for a very limited time to the general public and industry, it is based on the thinking of hundreds of FSIS employees and ten review teams who were invited to present their ideas for future design of the FSIS.
You may see action on many of these "concepts" by the end of 1995, while others may be considered for phase-in over a several year period. Some elements are looked at for a two- to four-year time line.
Farm-To-Table - Without control of every step in the food chain from production to home preparation, it is impossible to guarantee absolute food safety. To expand its role beyond the inspected plant, FSIS considers the following:
For Animal Production - Reducing risk for product brought into plants will involve voluntary efforts in model production and certification programs. With present limited jurisdiction, FSIS will rely on agency personnel to validate these programs or work with third-party certifiers upon request. Exporting operations will be able to request USDA certification of food safety-quality assurance livestock producer programs. USDA will set targets for pathogen reduction for animals entering the plant and use diagnostic tests to screen for diseased animals, residues and pathogens.
For In-Plant Operations - FSIS will shift more resources to food safety, meaning less emphasis on aesthetic and economic issues. Currently, only about 40% of agency inspection efforts are channeled to food safety, with the rest devoted to areas of labeling, weights, blueprints, etc. Look for a shift to 70-80% of FSIS resources devoted to food safety.
For Transportation/Storage Sector - This fall FSIS expects to issue an advance notice of proposed rulemaking aimed at controls to minimize growth of pathogens during phases of transportation and storage. USDA will rely on industry trade groups to promote and transporters and storage firms to adopt systems for handling product. Primary emphasis here will be on temperature control. This means zero degrees for frozen products, but the temperature for refrigerated product has not yet been determined. FSIS has toyed with the 40-degree standard, but it seems very unscientific and could have an enormous economic consequence. AAMP suggests standards based on the actual product shipped or held make more sense, but firms may have to validate that these temperatures are appropriate for each product.
On the matter of jurisdiction, FSIS has historically said transport, delivery, or storage facilities owned or operated by the inspected plant are fair game for its regs. Legislation may be needed to control commercial haulers and storage operations, but FSIS still has a hook in those areas. It could require each plant shipping inspected product or receiving product to verify the conditions of transport or storage if the plant paid the freight or ordered freight service for its customers.
For Retail & Restaurants - FSIS will continue to exercise direct jurisdiction for product adulteration or misbranding at retail. Enforcement now includes product control actions such as voluntary destruction, detention and judicial seizure, as well as warning letters or referrals for criminal action.
The agency plans to support adoption of model food codes and will assist state and local enforcement of adulteration and misbranding aspects of the codes. FSIS plans to audit state and local agency inspection and enforcement programs for regulation of meat and poultry processing and handling, while standardizing procedures for these officials, even if the state or local jurisdiction did not adopt a food code.
Food handling and consumer education will receive major emphasis, with restaurants coming under surveillance. FSIS will develop a priority list for the educational process.
International Programs - Plants wishing to export to the U. S. will be subject to FSIS' assessment of the foreign inspection system's ability to validate and verify in-plant HACCP systems or their equivalent. Monitoring and verification procedures will determine types and intensity of port-of-entry inspection.
FSIS' Regulatory Role - One of the most significant changes will be FSIS' redefining its role in food safety and that, of course, means the changing tasks of the traditional in-plant inspector. Future regulatory activity will be based on public health impact, including biological, physical or chemical properties; long-term known or potential impact on public health, unknown health and safety issues, and, most importantly, the impact on population sub-groups. Read this to mean that the agency will define whether meat and poultry standards will be targeted for a normal, healthy person or for the immunocompromised population.
This latter group could include everyone from persons with weakened tolerance systems (AIDS, cancer patients, pregnant women, etc.). It is likely FSIS will move to that standard, basing its argument on the proposition that at least once a year as much as one-sixth of the general population is in a compromised state (colds, fevers, flu, etc.).
You will see FSIS looking more at the product and the process and less at the physical establishment. Hazard Analysis Critical Control Point (HACCP) will be a mainstay for the agency as it moves in this direction. Under this concept FSIS will review Critical Control Point (CCP) monitoring records of the plant, review records for handling process deviations, review plant verification records, physically observe CCP monitoring and verification by the plant, observe plant handling of process deviations and collect samples for lab analysis.
These activities would be scheduled with time to completely review an entire process. For plants with more than one process (meaning more than one HACCP program), verification activities would be scheduled to ensure that all HACCP plans are covered at least once a month. Compliance over time would mean less frequent verification. Some key steps:
Verification - Inspector checks to see that the plant is doing what is in its process control or HACCP plan. This may last several hours or perhaps one day.
Validation - FSIS evaluates the plant's HACCP plan to be certain it is appropriate and works for the product and process covered. A target frequency for validation audit would be at least once every two years for every HACCP plan. This is likely to involve an FSIS out-of-plant technical person or team and take several days to a week, but will occur on site.
Antimortem & Postmortem Inspection - Here you may expect a change within a two- to four-year period in which the plant is held responsible for presenting for inspection only animals eligible for use as human food. The plant would be asked to sort normal from abnormal animals before inspection, with FSIS maintaining carcass-by-carcass approval. This would be most applicable to larger, single species slaughter plants.
The agency says in red meat operations, the plant would assume responsibility for making incisions in certain lymph nodes and muscles, condemning or rejecting animals and marking carcasses for trim. However, no trimming will be permitted prior to FSIS inspection. FSIS is studying assignment responsibility between plant and inspector, with the list at four options for beef and poultry and three for swine.
Economic Verification - Also in the two- to four-year range is an agency plan for covering areas of misbranding, fraud or economic adulteration. One option calls for use of the present nutritional labeling rules, while another would add percentage labeling for all ingredients. FSIS is wrestling with conducting nutritional labeling verification, something it does not now do, or allowing the marketplace to detect problems. Net weights would be relegated to state enforcement.
Sanitation Standard Operating Procedures - Known as SOP's, these written plans on how a plant will control sanitation are kindred to establishment of good manufacturing practices by a plant. This is a basic sanitation, cleanliness item that is in addition to the HACCP plan that controls critical process areas where a product could become unsafe. A plant that failed to develop and adhere to such plans would be said to exhibit presumptive evidence of insanitary conditions and face swift enforcement action. Consistent with the HACCP approach, SOP compliance could trigger less frequent on-site inspection.
A question yet unanswered: Will SOP's apply to overall plant operations or solely to direct product contamination? It's a big question since the latter option dismisses FSIS direct monitoring in areas of employee dress, hygiene, operational and pre-operational sanitation, product flow, pest and rodent control. The plant would still be responsible, but with no specific guidelines or standards.
Facility & Equipment Verification - FSIS will momentarily be publishing a proposal that would virtually eliminate prior approval rules for blueprints, equipment and many labels. It could be one of the most controversial issues of the review.
The agency suggests that a "Reviewers Instruction Manual" for use by field personnel can deal with blueprint acceptance and criteria found in the Accepted Meat & Poultry Equipment directive will suffice to guide field staff to proper decisions. We are dealing with real people here, who have good days and bad days. To trust the purchase of a $15,000 machine to the approval of the local inspector, or his rotated replacement, would chill plant operators to the bone. Inspectors change, not just in rotation, but in attitude. They also change their minds and take the field with 17% of their number who do not have a high school education. Decisions in this area are already controversial, with approval granted at one level and rejected at another. Even today, inspectors reject some equipment listed in the "accepted" catalog.
FSIS is chasing three options on the equipment issue, all involving no Washington approval. One would have the manufacturer self-certify equipment based on standards for sanitary design and construction; another would use a third party like Underwriters Laboratory (UL); while the third would call for equipment to be certified in compliance with certain standard setting entities, such as American National Standards Institute. In all instances, in-plant inspectors would monitor the equipment during operation for "sanitary performance that does not adulterate the product or create a nuisance in the plant.
For new construction, a circuit supervisor (CS) would issue approvals or rejections of plans. For existing facilities, two options are offered by FSIS: one, the Inspector In Charge (IIC) approves minor changes and the CS major changes; or, second, the IIC is responsible for all facility approval. FSIS says this might save some paperwork. Get the aspirin.
Enforcement - As the agency moves from specifications standards to "performance standards", it will target enforcement on process failure. If this means more subjective calls by inspectors without a fair, prompt appeal system in place, tell your kids to look for a new line of work. This quote from FSIS as it forecasts implementation changes: "Initially this environment may result in more enforcement actions and subsequent court decisions, but as plants adjust to their responsibilities the agency anticipates that the number of court cases will decrease."
This involves a cultural change in which the FSIS moves from a "command and control" inspection approach to one in which the plant is held responsible for everything. Rather than find the paper towel holder empty and say "gotcha", tomorrow the inspector may just close you down and see you in court.
FSIS says rather than emphasis on summary actions, future inspector emphasis will be on gathering evidence to support suspension and filing of formal complaints, using your HACCP and SOP records, rather than the inspector's, to nail you.
Seems to us that an inspector seeing any contamination should point it out, rather than let it go through the system and onto a consumer's plate. A court date two months later misses the whole point of public safety and detection of food safety problems. Yes, the mentality will be changing but we are fearful that a few of the inspectors afflicted with "swollen badge syndrome" would rather not deal with an immediate food safety problem that could prevent a food safety problem and opt instead for a chance to get their man.
Deficiencies - Deviations from a HACCP or SOP control program will have three levels of seriousness, FSIS suggests.
a.) Low Level: there are steps in the plant's process that may correct the deficiency. (e.g., another kill step or chance to review records);
b.) Middle Level: there are no steps in the plant's process, but product is not shipped and a chance of record review may catch the problem;
c.) High Level: product shipped, product adulterated.
The agency proposes that the plant's performance (number and type of deficiencies) is in a three-month moving window, with only the current window counting for in-plant inspector response; however, once an enforcement team would be called in to investigate food safety non-compliance, all deficiencies and deviations would count. FSIS says the use of civil penalties (a la OSHA, IRS) should be examined.
Separation Of Industry & USDA Roles - FSIS says industry uses inspectors for many management, consultant and quality control purposes. It maintains the need to change that role and offers a few options. By seeking to manage every aspect of production, FSIS has created an industry-wide mind-set that everything in a plant is O.K. unless an inspector finds a problem and directs corrective action, FSIS adds.
An FSIS plan would terminate the closeness in relationships between inspection personnel and plant management by closing out the continuous presence of the inspector. It means future enforcement requires identifying a plant violation and applying the appropriate penalty - no USDA fixes and no multiple warnings.
In addition to the civil fines, FSIS called for earlier, it will ask for product recall authority (although no voluntary request for recall has ever been denied). The agency says it must afford "due process" to plants and offer a formal appeals process.
Economic Adulteration - Contending it will lack resources to deal with aesthetic, adulteration, misbranding and economic issues at the present level, FSIS proposes checking labels at the finished product stage rather than during production.
But the agency presents two additional options. The first would be development of new testing protocols to verify product standards. The second, more controversial, would abandon product standards. FSIS leans toward the last option. It's along the lines of thinking that if we took down all the speed limit signs, we would have no speeders.
Label truthfulness, FSIS says, would be the ultimate test, with all ingredients and amounts listed. This would be a boon to new-product innovation, they add. Think this one through carefully in terms of competitors outside the realm of inspection who market products with formulations not permitted under inspection.
Seal Of Inspection - Liability is a scare word for the legal background folks who run FSIS. They are afraid of litigation from consumers who eat an unwholesome product with the USDA seal signifying "wholesome" or "inspected and passed." FSIS thinks label language such as "prepared under a HACCP processing system" is more truthful, appropriate, and gets them off the liability hook.
Third Parties - The agency is considering use of third-party approval for blueprint, equipment, label, etc., that plants could hire for a fee. It might limit plant liability to a degree and could keep FSIS out of hot water entirely.
Team Inspection - Rather than having an individual inspector, plants could deal with an inspection team formed at what is now the circuit supervisor level. Problems with plants would be correlated at team meetings and inspection plans outlined. It could involve several or all team members descending on a deviating plant. Inspectors would be rotated to avoid linkage with the plant and the circuit supervisor could serve as the team "coach." That's a clear signal the adversarial role of FSIS in 1995 is in for enhancement, not teaming with plant management to work together toward improved product safety.
A longer-range team approach would use technical experts in a variety of fields, including compliance, HACCP, facilities and equipment, labeling, veterinary medicine, processing, and other disciplines. They would be used to cover the farm-to-table realm in a geographic area. FSIS says it is all ready to move with a pilot test of the team approach.
Inspector Office, Ratings & Image - Contending inspectors' offices in plants contribute to role confusion, FSIS might eliminate them. This means they would not be drawn in to solve plant problems, according to USDA.
Inspector performance ratings would be divorced from plant ratings and in the future tied to how the inspector functions effectively and efficiently in a HACCP/SOP plant.
The image of inspection personnel must change, FSIS says. It may mean distinguishing them from plant employees through dress or even changing the title from "inspector" to something reflecting the role as a government regulator. Funny, but we never had a problem distinguishing workers in a plant from inspectors. USDA may welcome your suggestions on what to call inspectors. And, where will they sleep?
Structural Changes - Reassessing the need for five regional offices and 26 area offices, FSIS now suggests consolidating them into 8, 12 or 15 "district offices." Lumped in with them would be the five compliance and six international program field offices. A review team type person may be assigned to each office, but the review team as we know it will be a thing of the past, allowing Lawrence, Kansas, an opportunity to reclaim its past reputation as a nice place. Present circuit boundaries would disappear.
Sites Of District Offices - If FSIS goes with 15 district offices, suggested sites would be:
Albany/Boston Ft. Washington/Philadelphia Jackson
Raleigh/Louisville Harrisburg/Greenbelt Pickerington
Athens/Atlanta Chicago/Madison Ames/Des Moines
Springdale Austin/Dallas Jefferson City
Long Beach Alameda/Sacramento Boulder
The scenario with 12 district offices:
Long Beach/Alameda/Sacramento Boulder/Topeka
Baton Rouge/Dallas/Austin Des Moines/Ames/Madison
Chicago/Springfield Louisville/Pickerington
Athens/Atlanta Greenbelt/Raleigh
Harrisburg/Philadelphia Albany/Boston
Springdale Tallahassee/Athens
Under the 8 district office plan:
Philadelphia/Ft. Washington Greenbelt/Raleigh
Atlanta/Athens Dallas/Springdale
Pickerington/Chicago Ames/Des Moines
Boulder/Topeka Sacramento/Alameda
One other option under consideration would combine various components of the existing structure into five regions. The number of circuits would drop from 179 to 140 and compliance, egg product, import field office, and other functions would be merged in with meat and poultry inspection offices. FSIS doesn't seem to high on this latter option at first reading, but whichever way it goes, the level of appeal and supervision would be reduced by one.
State Inspection - FSIS will seek and obtain an amendment to the meat and poultry inspection acts allowing state-inspected meat and poultry products to be shipped in interstate commerce. Funding for 50% of the state programs now provided by FSIS would be switched to a block grant approach to states. While the fairness and common sense of allowing "equal to" inspected U. S. plants to ship to their natural marketing areas is commendable, the funding approach could kill state inspection programs, which now cover 2,500 plants, since other social programs will compete for dollars at the state level with the diminished presence of the federal government's funding for these programs.
Continuous Inspection - USDA has "reinterpreted" its requirement for "continuous inspection" for processing operations. Under the new view, regulations would no longer require more than a daily in-plant inspection presence and would enable FSIS managers to selectively cover a second or third shift. Simply put, it means more patrol inspections and the overtime ramifications of the word "selectively" is still an unknown. The agency says sampling for compliance with product standards could constitute "continuous inspection" for economic, quality and aesthetic mandates for wholesomeness in both processing and slaughter, as could the evaluation of records.
Similar adjustments are to occur in slaughter operations, with FSIS taking what it calls a "minimalist" approach to its present mandate for carcass-by-carcass inspection.
Tomorrow's Inspector - Remembering that the FSIS document was compiled by its own employees, one should be acutely aware of the shortfalls in inspector training and discipline that were brought forward. And, the plan calls for addressing these problem areas head-on.
In both hiring and training, FSIS says interpersonal skills' areas deserve increased attention. Amen. This new emphasis includes listening, oral communication and writing skills. FSIS elaborates that interpersonal skills in dealing with plant management, especially as problems arise, need sharpening. Future inspectors will be taught to understand their own psychological type and what impact it has on interactions and perceptions, as well as decision-making. They will be taught to understand the benefits derived from a good regulator-plant management relation's program and to better understand, appreciate and tolerate preferences and differences in others, including opposite types.
The agency says that joint industry-program training could close the cultural change gap more rapidly to promote improved understanding. These principles must be reinforced daily by field and headquarters management . . . in FSIS' words.
At the same time, inspectors will be told where they inspect is not my plant and operators will be advised that the person handling FSIS functions is not my inspector. A new identity relationship of arm's length relationships is in the cards.
As HACCP/SOP comes on line, the new training in cultural change needs to come on line before in-plant implementation, the agency says. FSIS trainers will deliver on-site field training prior to the scheduled HACCP implementation. In the concept of joint training, FSIS offers that industry be charged to attend the joint sessions. And, for HACCP plants, FSIS recommends some type of certification process be used to accredit its employees for validation team participation.
More importantly, the suggestion that a test of "practical, on-the-job" skills be passed before inspectors are deemed qualified is being taken seriously.
Changing the mind-set of the present inspection force is seen as a formidable, but doable task. Inspectors are displeased with the lack of communications, unnecessary paperwork and the lack of disciplinary actions taken against IIC's and CS's not performing their jobs. At the same time, inspectors are basically mistrustful of industry and leery of their ability to enforce HACCP. They've suggested jail sentences, plant closings, heavy financial penalties and heavy publicity as better enforcement tools.
They also called for faxes, computers, car phones, beepers, voice and electronic mail, small micro labs and quick micro test kits to enhance their performance abilities.
However, many inspectors agreed that there are too many repetitive and confusing regulations, usually requiring notices to explain them. They complained of lack of uniformity in interpreting rules, outdated rules and the need for those writing rules to talk to field personnel.